<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972541</url>
  </required_header>
  <id_info>
    <org_study_id>2016-161-1</org_study_id>
    <nct_id>NCT02972541</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer</brief_title>
  <acronym>NACSOC</acronym>
  <official_title>NeoAdjuvant Chemotherapy Versus Surgery Alone After Stent Placement for Left-sided Obstructive Colonic Cancer:a Multicenter, Controlled, Open-label Clinical Trial (NACSOC Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with&#xD;
      colorectal cancer present with an emergency obstruction of the large bowel at the time of&#xD;
      diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with&#xD;
      obstruction are associated with worse oncologic outcomes compared with those having&#xD;
      nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction&#xD;
      receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and&#xD;
      about two-thirds of such patients end up with a permanent stoma.&#xD;
&#xD;
      Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve&#xD;
      obstruction prior to elective surgery) in patients with potentially resectable colorectal&#xD;
      cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior&#xD;
      to emergency surgery considering the short-term outcomes. SEMS is associated with lower&#xD;
      morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma&#xD;
      creation rate. Although about half of patients can achieve primary anastomosis after stent&#xD;
      placement, the primary anastomosis rate is still significantly lower compared with&#xD;
      nonobstructing elective surgery. The interval between stent placement and surgery may be not&#xD;
      long enough that bowel decompression is insufficient at the time of operation.&#xD;
      Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still&#xD;
      limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with&#xD;
      SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was&#xD;
      significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation&#xD;
      is that tumor cells may disseminate during the procedure of colonic stenting placement. We&#xD;
      hypothesis that immediate chemotherapy after stenting may improve overall survival by&#xD;
      eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between&#xD;
      stent placement and surgery, and the time for bowel decompression is more sufficient, which&#xD;
      may increase the success rate of primary anastomosis and decrease risk of stoma formation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>September 30, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of stoma formation</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical complication</measure>
    <time_frame>From date of randomization until the first follow-up ended, assessed up to 30 days</time_frame>
    <description>Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis,perioperative mortality, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of primary colorectal anastomosis</measure>
    <time_frame>From date of randomization until the first follow-up ended, assessed up to 30 days</time_frame>
    <description>The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>From date of randomization until the first follow-up ended, assessed up to 30 days</time_frame>
    <description>R0 resection is defined as negative resection margins and no residual tumor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation rate</measure>
    <time_frame>From date of randomization until the follow-up ended, assessed up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy complete rate</measure>
    <time_frame>From date of randomization until the chemotherapy ended, assessed up to 1 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy related complication</measure>
    <time_frame>From date of randomization until the chemotherapy ended, assessed up to 1 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">248</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Neoadjuvant Chemotherapy</condition>
  <condition>Stent</condition>
  <condition>Obstruction</condition>
  <arm_group>
    <arm_group_label>Stenting with neoadjuvant chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After clinical success of colonic stenting, patients will receive neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 3-5 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stenting with Immediate Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After clinical success of colonic stenting, patients will undergo surgery 7-14 days after inclusion. Type and extent of the elective surgery will be selected by the surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stenting with neoadjuvant chemotherapy</intervention_name>
    <description>After clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.</description>
    <arm_group_label>Stenting with neoadjuvant chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stenting with immediate Surgery</intervention_name>
    <description>After clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.</description>
    <arm_group_label>Stenting with Immediate Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiologically proven colonic obstruction of the left colon/upper rectum presumed&#xD;
             secondary to a carcinoma&#xD;
&#xD;
          -  Able to give written, informed consent&#xD;
&#xD;
          -  Primary tumor was resectable&#xD;
&#xD;
          -  ECOG score 0 or 1&#xD;
&#xD;
          -  Haemoglobin greater than 100 g/L after transfusion before chemotherapy,&#xD;
&#xD;
          -  White blood cells greater than 3.0×10⁹ /L&#xD;
&#xD;
          -  Platelets greater than 100×10⁹ / L;&#xD;
&#xD;
          -  Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright&#xD;
             or Cockroft formula&#xD;
&#xD;
          -  Bilirubin less than 1.5×Upper Limit of Normal(ULN)&#xD;
&#xD;
          -  ALT and AST less than 2.5×ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distal rectal cancers(equal or less than 10cm from the anal verge)&#xD;
&#xD;
          -  Patients with signs of peritonitis and/or bowel perforation&#xD;
&#xD;
          -  Patients who did not give informed consent&#xD;
&#xD;
          -  Patients who were considered unfit for operative treatment or refuse surgery.&#xD;
&#xD;
          -  Patients with suspected or proven metastatic adenocarcinoma;&#xD;
&#xD;
          -  Patients with unresectable colorectal cancer, or planning for palliative treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhenjun wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhenjun wang, MD</last_name>
    <phone>8610-85231604</phone>
    <email>drzhenjun@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>weigen zeng, MD</last_name>
    <phone>8610-85231604</phone>
    <email>shen_coco@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhen Jun Wang, M.D.</last_name>
      <phone>86-013601393711</phone>
      <email>drzhenjun@163.com</email>
    </contact>
    <investigator>
      <last_name>Zhen Jun Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhongtao zhang, MD</last_name>
      <phone>8610-63016616</phone>
      <email>yaohongwei@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>gang xiao, MD</last_name>
      <phone>8610-85132266</phone>
      <email>xgbj@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaohui du, MD</last_name>
      <email>duxiaohui301@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>fei li, MD</last_name>
      <email>feili36@ccmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xi-shan wang, MD</last_name>
      <phone>8610-87787110</phone>
      <email>794157254@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Sixth Affiliated Hospital of Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lei wang, MD</last_name>
      <phone>8620-38254011</phone>
      <email>wangl9@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wei-zhong tang, MD</last_name>
      <email>13978157758@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medicial University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>guiying wang, MD</last_name>
      <phone>86311-86095588</phone>
      <email>tizq12@vip.163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Jiamusi University</name>
      <address>
        <city>Jiamusi</city>
        <state>Heilongjiang</state>
        <zip>154003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>fujun chen, MD</last_name>
      <email>gck8801079@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the 150th Central Hospital of Chinese PLA</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>dong wei</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>weitang yuan, MD</last_name>
      <email>13978157758@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Second Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhigang pang, MD</last_name>
      <email>pzg63726@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>keliang zhang, MD</last_name>
      <phone>8627-87670242</phone>
      <email>13071238088@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hubei General Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>shilun tong, MD</last_name>
      <email>tongshilun@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>qun qian, MD</last_name>
      <phone>86-013098824999</phone>
      <email>qunqian2007@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaorong li, MD</last_name>
      <email>lixiaorong@medmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hunan Provincial People'S Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhongcheng huang, MD</last_name>
      <phone>86731-83929555</phone>
      <email>huangzc369@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>China-Japan Union Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>tongjun liu, MD</last_name>
      <email>tongjunliu@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yong feng, MD</last_name>
      <email>fengy@sj-hospital.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Shandong</state>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wei bi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Qianfoshan Hospital</name>
      <address>
        <city>Jinan Shi</city>
        <state>Shandong</state>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lijian xia, MD</last_name>
      <email>xiaalbert2758@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong General Hospital</name>
      <address>
        <city>Jinan Shi</city>
        <state>Shandong</state>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>changqing jing, MD</last_name>
      <email>jing66510122@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Dai, M.D.</last_name>
      <email>18560085128@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yun lu, MD</last_name>
      <email>cloudylucn@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>chuangang fu, MD</last_name>
      <email>fugang416@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Tumor Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaobo liang, MD</last_name>
      <phone>860351-4651714</phone>
      <email>liangxiaobo@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Xi'An Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiangming che, MD</last_name>
      <email>chexiang@mail.xjtu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zi-qiang wang, MD</last_name>
      <email>wangzqzyh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jianjiang lin, MD</last_name>
      <email>ljjzju@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinhua Hospital of Zhejiang University</name>
      <address>
        <city>Jinhua</city>
        <state>Zhejiang</state>
        <zip>321000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jinlin du, MD</last_name>
      <email>djl9090@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Second Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>changbao liu, MD</last_name>
      <email>lcb@wzhealth.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sabbagh C, Browet F, Diouf M, Cosse C, Brehant O, Bartoli E, Mauvais F, Chauffert B, Dupas JL, Nguyen-Khac E, Regimbeau JM. Is stenting as &quot;a bridge to surgery&quot; an oncologically safe strategy for the management of acute, left-sided, malignant, colonic obstruction? A comparative study with a propensity score analysis. Ann Surg. 2013 Jul;258(1):107-15. doi: 10.1097/SLA.0b013e31827e30ce.</citation>
    <PMID>23324856</PMID>
  </reference>
  <reference>
    <citation>van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3. Erratum In: Lancet Oncol. 2011 May;12(5):418.</citation>
    <PMID>21398178</PMID>
  </reference>
  <reference>
    <citation>Young CJ, De-Loyde KJ, Young JM, Solomon MJ, Chew EH, Byrne CM, Salkeld G, Faragher IG. Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion. Dis Colon Rectum. 2015 Sep;58(9):838-49. doi: 10.1097/DCR.0000000000000431.</citation>
    <PMID>26252845</PMID>
  </reference>
  <reference>
    <citation>Huang X, Lv B, Zhang S, Meng L. Preoperative colonic stents versus emergency surgery for acute left-sided malignant colonic obstruction: a meta-analysis. J Gastrointest Surg. 2014 Mar;18(3):584-91. doi: 10.1007/s11605-013-2344-9. Epub 2013 Oct 30.</citation>
    <PMID>24170606</PMID>
  </reference>
  <reference>
    <citation>Ohman U. Prognosis in patients with obstructing colorectal carcinoma. Am J Surg. 1982 Jun;143(6):742-7. doi: 10.1016/0002-9610(82)90050-2.</citation>
    <PMID>7046484</PMID>
  </reference>
  <reference>
    <citation>Kim JS, Hur H, Min BS, Sohn SK, Cho CH, Kim NK. Oncologic outcomes of self-expanding metallic stent insertion as a bridge to surgery in the management of left-sided colon cancer obstruction: comparison with nonobstructing elective surgery. World J Surg. 2009 Jun;33(6):1281-6. doi: 10.1007/s00268-009-0007-5.</citation>
    <PMID>19363580</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Zhen Jun Wang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972541
org study id: 2016-161-1
nct id: NCT02972541
lead sponsor: 
has dmc: Yes
Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with
      colorectal cancer present with an emergency obstruction of the large bowel at the time of
      diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with
      obstruction are associated with worse oncologic outcomes compared with those having
      nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction
      receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and
      about two-thirds of such patients end up with a permanent stoma.

      Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve
      obstruction prior to elective surgery) in patients with potentially resectable colorectal
      cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior
      to emergency surgery considering the short-term outcomes. SEMS is associated with lower
      morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma
      creation rate. Although about half of patients can achieve primary anastomosis after stent
      placement, the primary anastomosis rate is still significantly lower compared with
      nonobstructing elective surgery. The interval between stent placement and surgery may be not
      long enough that bowel decompression is insufficient at the time of operation.
      Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still
      limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with
      SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was
      significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation
      is that tumor cells may disseminate during the procedure of colonic stenting placement. We
      hypothesis that immediate chemotherapy after stenting may improve overall survival by
      eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between
      stent placement and surgery, and the time for bowel decompression is more sufficient, which
      may increase the success rate of primary anastomosis and decrease risk of stoma formation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival
time frame: From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years
measure: Overall survival
time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
measure: Rate of stoma formation
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
measure: Surgical complication
time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
description: Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis,perioperative mortality, etc.
measure: Rates of primary colorectal anastomosis
time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
description: The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis.
measure: R0 resection rate
time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
description: R0 resection is defined as negative resection margins and no residual tumor.
measure: Re-operation rate
time frame: From date of randomization until the follow-up ended, assessed up to 5 years
measure: Chemotherapy complete rate
time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
measure: Chemotherapy related complication
time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
arm group label: Stenting with neoadjuvant chemotherapy
arm group type: Experimental
description: After clinical success of colonic stenting, patients will receive neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 3-5 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon.
arm group label: Stenting with Immediate Surgery
arm group type: Active Comparator
description: After clinical success of colonic stenting, patients will undergo surgery 7-14 days after inclusion. Type and extent of the elective surgery will be selected by the surgeon.
intervention type: Device
intervention name: Stenting with neoadjuvant chemotherapy
description: After clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
arm group label: Stenting with neoadjuvant chemotherapy
intervention type: Device
intervention name: Stenting with immediate Surgery
description: After clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
arm group label: Stenting with Immediate Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: zhenjun wang, MD
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: zhenjun wang, MD
phone: 8610-85231604
email: drzhenjun@163.com
last name: weigen zeng, MD
phone: 8610-85231604
email: shen_coco@163.com
facility: 
status: Recruiting
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country: China
citation: Sabbagh C, Browet F, Diouf M, Cosse C, Brehant O, Bartoli E, Mauvais F, Chauffert B, Dupas JL, Nguyen-Khac E, Regimbeau JM. Is stenting as "a bridge to surgery" an oncologically safe strategy for the management of acute, left-sided, malignant, colonic obstruction? A comparative study with a propensity score analysis. Ann Surg. 2013 Jul;258(1):107-15. doi: 10.1097/SLA.0b013e31827e30ce.
PMID: 23324856
citation: van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3. Erratum In: Lancet Oncol. 2011 May;12(5):418.
PMID: 21398178
citation: Young CJ, De-Loyde KJ, Young JM, Solomon MJ, Chew EH, Byrne CM, Salkeld G, Faragher IG. Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion. Dis Colon Rectum. 2015 Sep;58(9):838-49. doi: 10.1097/DCR.0000000000000431.
PMID: 26252845
citation: Huang X, Lv B, Zhang S, Meng L. Preoperative colonic stents versus emergency surgery for acute left-sided malignant colonic obstruction: a meta-analysis. J Gastrointest Surg. 2014 Mar;18(3):584-91. doi: 10.1007/s11605-013-2344-9. Epub 2013 Oct 30.
PMID: 24170606
citation: Ohman U. Prognosis in patients with obstructing colorectal carcinoma. Am J Surg. 1982 Jun;143(6):742-7. doi: 10.1016/0002-9610(82)90050-2.
PMID: 7046484
citation: Kim JS, Hur H, Min BS, Sohn SK, Cho CH, Kim NK. Oncologic outcomes of self-expanding metallic stent insertion as a bridge to surgery in the management of left-sided colon cancer obstruction: comparison with nonobstructing elective surgery. World J Surg. 2009 Jun;33(6):1281-6. doi: 10.1007/s00268-009-0007-5.
PMID: 19363580
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Zhen Jun Wang
investigator title: professor
mesh term: Colonic Neoplasms
sharing ipd: No