<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/NCT03245203</url>
  </required_header>
  <id_info>
    <org_study_id>20170801001</org_study_id>
    <nct_id>NCT03245203</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer</brief_title>
  <official_title>A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has&#xD;
      become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to&#xD;
      reduce the local recurrence rate, however, no improvement of distant metastasis rate was&#xD;
      observed, and the incidence of postoperative local recurrence and distant metastasis can&#xD;
      reach more than 25%. It is still a challenge for us to improve the RO resection rate of&#xD;
      locally advanced rectal cancer and reduce the incidence of local recurrence and distant&#xD;
      metastasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has&#xD;
      shown better compliance of LARC patients, and may be more effective in reducing the incidence&#xD;
      of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs&#xD;
      beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and&#xD;
      investigated the short-term efficacy to provide objective basis for the selection of&#xD;
      neoadjuvant therapy.&#xD;
&#xD;
      Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III&#xD;
      were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant&#xD;
      radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>3 years</time_frame>
    <description>percent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease-free survival (DFS)</measure>
    <time_frame>3 years</time_frame>
    <description>year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>3 years</time_frame>
    <description>year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall response rate (ORR)</measure>
    <time_frame>3 years</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>neoadjuvant CRT for consecutive 5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FOLFIRI+beacizumab</intervention_name>
    <description>Eligible patients received bevacizumab 5.0 mg/kg followed by irinotecan 125mg/m2 combined with LV 200mg/m2 followed by 5-FU bolus 400mg/m2,then 5-FU infusion 2.4~3.0g/m2 over a 46-h period.Those agents were given for a 2-week cycle.Treatment was administered for six cycles. LARC was reevaluated and operated after 4~8 weeks.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CRT</intervention_name>
    <description>total dose of radiotherapy was 40~50Gy, a subdose of 1.8~2Gy for continuous 5 weeks, 5 times/week.Then,5-FU infusion 400mg/m2 combined with LV 200mg/m2 over 24 h for 4 days/week during the first and fifth weeks of radiotherapy.Whereas,Capecitabine was administered orally at a dose of 825mg/m2 twice a day for 5 days of a week. Second staging and operation were performed in the sixth week after chemoradiotherapy.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperative&#xD;
             biopsy pathology report, endoscopic examination report and preoperative abdominal&#xD;
             pelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesions&#xD;
             within 4~12 cm from the anus through endoscopic examination; 3. No distant metastasis&#xD;
             and intestinal obstruction; 4. No surgical contraindications; 5. Can be treated with&#xD;
             neoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consent&#xD;
             with patients and family members before treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of beacizumab allergy, being treated with other therapy important viscera&#xD;
             dysfunction and severe heart disease, including congestive heart failure, arrhythmia&#xD;
             beyond the control, long-term drug treatment of angina pectoris, heart valve disease,&#xD;
             myocardial infarction, and resistant hypertension; infectious wound and uncontrollable&#xD;
             history of mental illness; infectious sexual diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nan du</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>nan du</last_name>
    <phone>13911599657</phone>
    <email>dunan304@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital, Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>DuNan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>neoadjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT03245203
org study id: 20170801001
nct id: NCT03245203
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has
      become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to
      reduce the local recurrence rate, however, no improvement of distant metastasis rate was
      observed, and the incidence of postoperative local recurrence and distant metastasis can
      reach more than 25%. It is still a challenge for us to improve the RO resection rate of
      locally advanced rectal cancer and reduce the incidence of local recurrence and distant
      metastasis.
Objective: compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has
      shown better compliance of LARC patients, and may be more effective in reducing the incidence
      of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs
      beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and
      investigated the short-term efficacy to provide objective basis for the selection of
      neoadjuvant therapy.

      Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III
      were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant
      radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.
primary purpose: Treatment
masking: Single (Participant)
measure: R0 resection rate
time frame: 3 years
description: percent
measure: disease-free survival (DFS)
time frame: 3 years
description: year
measure: overall survival (OS)
time frame: 3 years
description: year
measure: overall response rate (ORR)
time frame: 3 years
description: percent
arm group label: Experimental group
arm group type: Experimental
description: beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)
arm group label: Control group
arm group type: Active Comparator
description: neoadjuvant CRT for consecutive 5 weeks
intervention type: Procedure
intervention name: FOLFIRI+beacizumab
description: Eligible patients received bevacizumab 5.0 mg/kg followed by irinotecan 125mg/m2 combined with LV 200mg/m2 followed by 5-FU bolus 400mg/m2,then 5-FU infusion 2.4~3.0g/m2 over a 46-h period.Those agents were given for a 2-week cycle.Treatment was administered for six cycles. LARC was reevaluated and operated after 4~8 weeks.
arm group label: Experimental group
intervention type: Procedure
intervention name: CRT
description: total dose of radiotherapy was 40~50Gy, a subdose of 1.8~2Gy for continuous 5 weeks, 5 times/week.Then,5-FU infusion 400mg/m2 combined with LV 200mg/m2 over 24 h for 4 days/week during the first and fifth weeks of radiotherapy.Whereas,Capecitabine was administered orally at a dose of 825mg/m2 twice a day for 5 days of a week. Second staging and operation were performed in the sixth week after chemoradiotherapy.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: nan du
role: Principal Investigator
affiliation: First Affiliated Hospital, Chinese PLA General Hospital
last name: nan du
phone: 13911599657
email: dunan304@163.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: DuNan
investigator title: Principal Investigator
mesh term: Rectal Neoplasms
sharing ipd: No