<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/NCT04405206</url>
  </required_header>
  <id_info>
    <org_study_id>BJCC-R01</org_study_id>
    <nct_id>NCT04405206</nct_id>
  </id_info>
  <brief_title>Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer</brief_title>
  <acronym>BJCC-R01</acronym>
  <official_title>Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for MRI Stratified Low-risk Rectal Cancer: a Multi-center, Prospective, Single-arm Phase II Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait&#xD;
      strategy (W&amp;W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by&#xD;
      total neoadjuvant treatment. Meanwhile we will look into the role of ctDNA in the prediction&#xD;
      of regrowth and metastasis in the wait and wait process.&#xD;
&#xD;
      Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor,&#xD;
      mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f&#xD;
      with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR&#xD;
      were recommended for 'watch &amp; wait' approach or local excision (LE). The OPR and sphincter&#xD;
      preservation rate (SPR) at 2 years will be analyzed.&#xD;
&#xD;
      As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research&#xD;
      enrolled 3 other colorectal center in Beijing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neoadjuvant chemoradiotherapy (nCRT), total mesorectal excision and adjuvant chemotherapy&#xD;
      comprise the standard treatment for locally advanced rectal cancer, following which 15-30%&#xD;
      patients achieved pathological complete response need to receive the removal of rectum&#xD;
      without residual tumor and suffer significant functional impairment even after sphincter&#xD;
      preservation. Adjuvant chemotherapy is also questioned for its benefit for prolonged survival&#xD;
      through the data from various studies. More evidence demonstrated that organ-preservation&#xD;
      (e.g. non-operative management or local excision) for patients with clinical complete&#xD;
      response (cCR) or near-cCR following nCRT had similar survival when compared with those&#xD;
      received standard care.&#xD;
&#xD;
      This study is designed to investigate the efficacy of neoadjuvant intensity modulated nCRT&#xD;
      with concurrent capecitabine plus consolidation CapeOX for T2/DWI/Enhanced MRI defined&#xD;
      cT2-T3b mid-low rectal cancer without threatening mesorectal fascia or extramural vascular&#xD;
      invasion (EMVI) or mrN2 disease.&#xD;
&#xD;
      According to the response to treatment evaluated by multi-modal assessment including digital&#xD;
      exam, T2/DWI/Enhanced MRI, endoscopy and serum CEA test, patients will receive tailored&#xD;
      operative management like local excision or total mesorectal excision, or non-operative&#xD;
      management. Intention to treatment was also allowed in this study.&#xD;
&#xD;
      Firstly, the investigators will observe the organ preservation rate at 2 years. Endpoints for&#xD;
      organ-preservation like non-regrowth DFS, stoma-free survival and other conventional survival&#xD;
      outcomes (DFS, OS) would be further collected. The short-term and long-term QoL will be&#xD;
      measured in all patients.&#xD;
&#xD;
      . Our baseline data showed the 48% of locally advanced rectal cancers could be downstaged to&#xD;
      stage ypT0-2N0 following IMRT with concurrent capecitabine. We hypothesize that at least 24%&#xD;
      of rectal cancers could be candidates for LE or NOM after IMRT and the rectum preservation&#xD;
      rate will increase to 40% in low-risk rectal cancers by LE or NOM following IMRT plus&#xD;
      consolidation CapeOX at 2 years. As a superiority design, this study need to recruit 64&#xD;
      patients to test this hypothesis, with 85% power (exact binomial test for proportions, alpha&#xD;
      = 5 %, one-sided), If the number of responses is 22 or more, the hypothesis that P &lt;= 0.240&#xD;
      is rejected. We anticipate about 10 % loss to follow-up, so we will recruit an additional 8&#xD;
      patients and the study will recruit 72 patients in all.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>OPR(organ preservation rate)</measure>
    <time_frame>3 year</time_frame>
    <description>Proportion of patients who achieved cCR or near cCR after neoadjuvant treatment and received watch and wait approach or local excision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NR-DFS(Non-regrowth disease free survival)</measure>
    <time_frame>3 year</time_frame>
    <description>Within 3 years after receiving the neoadjuvant treatment, the time patient in status free of death, local recurrence after radical resection or distant metastasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SFS(stoma-free survival)</measure>
    <time_frame>3 year</time_frame>
    <description>Within 3 years after receiving the neoadjuvant treatment, the time patient in status free of stoma</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Rectum Cancer</condition>
  <arm_group>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <description>Group A:Clinical complete response (cCR) Patients who achieve cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Nonoperative Management(NOM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <description>Patients who achieve near-cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Local Excision(LE) or Nonoperative Management(NOM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <description>Patients with residual tumor when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>OXA 130mg/m2</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <other_name>OXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Cape 1000mg/m2</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <other_name>Cape</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>intensity modulated radiotherapy</intervention_name>
    <description>IMRT 50.4Gy/22f</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DRE-Endoscopy-MRI-CEA</intervention_name>
    <description>examination process in follow up</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nonoperative Management</intervention_name>
    <description>Watch and Wait</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <other_name>NOM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local excision</intervention_name>
    <description>For ymriT1N0 and near-cCR patients，LE is optional.</description>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <other_name>LE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Mesorectal Excision</intervention_name>
    <description>Standard TME surgery openly or laporoscopically</description>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <other_name>TME</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality of Life Questionnaires</intervention_name>
    <description>QLQ C30 and QLQ CR29</description>
    <arm_group_label>Group A:Clinical complete response (cCR)</arm_group_label>
    <arm_group_label>Group B:Near-cCR</arm_group_label>
    <arm_group_label>Group C:Residual tumor</arm_group_label>
    <other_name>QLQ</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      FFPE and peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Rectal cancer patient who receives primary care in Beijing Cancer Hospital will be selected&#xD;
        as the candidate for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. the age is more than 18 years old and less than 85 years old;&#xD;
&#xD;
          -  2. ECOG score of physical condition is 0-1;&#xD;
&#xD;
          -  3. adenocarcinoma of rectum confirmed by pathology; differentiated into Grade 1-3,&#xD;
             i.e. high, medium and low differentiated adenocarcinoma&#xD;
&#xD;
          -  4. the distance from the lower edge of the tumor to the anal edge ≤ 12cm (endoscopy)&#xD;
             or to the anorectal ring (ARJ) ≤ 8cm;&#xD;
&#xD;
          -  5. the initial MRI was T2 / T3a / T3B, with negative EMVI and negative CRM. There was&#xD;
             no lymph node metastasis outside the ilium, general ilium, obturator and abdominal&#xD;
             aorta&#xD;
&#xD;
          -  6. the maximum diameter of tumor ≤ 4cm or the circumferentially invasive area is less&#xD;
             than 1 / 3 of intestinal circumference&#xD;
&#xD;
          -  7. no evidence of distant metastasis;&#xD;
&#xD;
          -  8. no history of pelvic radiotherapy;&#xD;
&#xD;
          -  9. no history of surgery or chemotherapy for rectal cancer;&#xD;
&#xD;
          -  10. systemic infection without antibiotic treatment;&#xD;
&#xD;
          -  11. blood routine test: neutrophil absolute value &gt; 1.5 × 10 9 / L, HGB &gt; 10.0 g / dl,&#xD;
             PLT &gt; 100 × 10 9 / L;&#xD;
&#xD;
          -  12. blood biochemistry: total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 4 x ULN;&#xD;
&#xD;
          -  13. the patient read and signed the informed consent of the study and agreed to&#xD;
             participate in the study;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. recurrent rectal cancer;&#xD;
&#xD;
          -  2. initial local non resectable rectal cancer (no possibility of R0 whole block&#xD;
             resection);&#xD;
&#xD;
          -  3. the creatinine level is 1.5 times higher than the upper limit of normal value;&#xD;
&#xD;
          -  4. have a history of pelvic radiotherapy;&#xD;
&#xD;
          -  5. the patients could not tolerate the enhanced MRI;&#xD;
&#xD;
          -  6. malignant tumors whose survival rate in the past 5 years is significantly lower&#xD;
             than that of rectal cancer in our center (excluding well treated basal cell carcinoma,&#xD;
             skin squamous carcinoma, small renal carcinoma, breast cancer and thyroid papillary&#xD;
             carcinoma);&#xD;
&#xD;
          -  7. in the past 6 months, the patients had arterial embolism diseases, such as angina,&#xD;
             MI, TIA, CVA, etc;&#xD;
&#xD;
          -  8. have received other types of anti-tumor or experimental treatment;&#xD;
&#xD;
          -  9. the patients are pregnant or lactating women;&#xD;
&#xD;
          -  10. patients with other diseases or mental disorders may affect their participation in&#xD;
             this study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yiming Zhao, M.D.</last_name>
    <phone>+8618600490721</phone>
    <phone_ext>18600490721</phone_ext>
    <email>iammike0721@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aiwen Wu, M.D.</last_name>
    <phone>+8613911577190</phone>
    <email>wuaw@hsc.pku.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yiming Zhao, M.D.</last_name>
      <phone>+8618600490721</phone>
      <email>liyingjiedr@sina.com</email>
    </contact>
    <investigator>
      <last_name>Aiwen Wu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Aiwen Wu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>rectum cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04405206
org study id: BJCC-R01
nct id: NCT04405206
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait
      strategy (W&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by
      total neoadjuvant treatment. Meanwhile we will look into the role of ctDNA in the prediction
      of regrowth and metastasis in the wait and wait process.

      Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor,
      mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f
      with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR
      were recommended for 'watch & wait' approach or local excision (LE). The OPR and sphincter
      preservation rate (SPR) at 2 years will be analyzed.

      As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research
      enrolled 3 other colorectal center in Beijing.
Neoadjuvant chemoradiotherapy (nCRT), total mesorectal excision and adjuvant chemotherapy
      comprise the standard treatment for locally advanced rectal cancer, following which 15-30%
      patients achieved pathological complete response need to receive the removal of rectum
      without residual tumor and suffer significant functional impairment even after sphincter
      preservation. Adjuvant chemotherapy is also questioned for its benefit for prolonged survival
      through the data from various studies. More evidence demonstrated that organ-preservation
      (e.g. non-operative management or local excision) for patients with clinical complete
      response (cCR) or near-cCR following nCRT had similar survival when compared with those
      received standard care.

      This study is designed to investigate the efficacy of neoadjuvant intensity modulated nCRT
      with concurrent capecitabine plus consolidation CapeOX for T2/DWI/Enhanced MRI defined
      cT2-T3b mid-low rectal cancer without threatening mesorectal fascia or extramural vascular
      invasion (EMVI) or mrN2 disease.

      According to the response to treatment evaluated by multi-modal assessment including digital
      exam, T2/DWI/Enhanced MRI, endoscopy and serum CEA test, patients will receive tailored
      operative management like local excision or total mesorectal excision, or non-operative
      management. Intention to treatment was also allowed in this study.

      Firstly, the investigators will observe the organ preservation rate at 2 years. Endpoints for
      organ-preservation like non-regrowth DFS, stoma-free survival and other conventional survival
      outcomes (DFS, OS) would be further collected. The short-term and long-term QoL will be
      measured in all patients.

      . Our baseline data showed the 48% of locally advanced rectal cancers could be downstaged to
      stage ypT0-2N0 following IMRT with concurrent capecitabine. We hypothesize that at least 24%
      of rectal cancers could be candidates for LE or NOM after IMRT and the rectum preservation
      rate will increase to 40% in low-risk rectal cancers by LE or NOM following IMRT plus
      consolidation CapeOX at 2 years. As a superiority design, this study need to recruit 64
      patients to test this hypothesis, with 85% power (exact binomial test for proportions, alpha
      = 5 %, one-sided), If the number of responses is 22 or more, the hypothesis that P <= 0.240
      is rejected. We anticipate about 10 % loss to follow-up, so we will recruit an additional 8
      patients and the study will recruit 72 patients in all.
observational model: Cohort
time perspective: Prospective
measure: OPR(organ preservation rate)
time frame: 3 year
description: Proportion of patients who achieved cCR or near cCR after neoadjuvant treatment and received watch and wait approach or local excision
measure: NR-DFS(Non-regrowth disease free survival)
time frame: 3 year
description: Within 3 years after receiving the neoadjuvant treatment, the time patient in status free of death, local recurrence after radical resection or distant metastasis.
measure: SFS(stoma-free survival)
time frame: 3 year
description: Within 3 years after receiving the neoadjuvant treatment, the time patient in status free of stoma
arm group label: Group A:Clinical complete response (cCR)
description: Group A:Clinical complete response (cCR) Patients who achieve cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Nonoperative Management(NOM).
arm group label: Group B:Near-cCR
description: Patients who achieve near-cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Local Excision(LE) or Nonoperative Management(NOM).
arm group label: Group C:Residual tumor
description: Patients with residual tumor when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation
intervention type: Drug
intervention name: Oxaliplatin
description: OXA 130mg/m2
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
arm group label: Group C:Residual tumor
other name: OXA
intervention type: Drug
intervention name: Capecitabine
description: Cape 1000mg/m2
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
arm group label: Group C:Residual tumor
other name: Cape
intervention type: Radiation
intervention name: intensity modulated radiotherapy
description: IMRT 50.4Gy/22f
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
arm group label: Group C:Residual tumor
other name: IMRT
intervention type: Procedure
intervention name: DRE-Endoscopy-MRI-CEA
description: examination process in follow up
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
arm group label: Group C:Residual tumor
intervention type: Procedure
intervention name: Nonoperative Management
description: Watch and Wait
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
other name: NOM
intervention type: Procedure
intervention name: Local excision
description: For ymriT1N0 and near-cCR patients，LE is optional.
arm group label: Group B:Near-cCR
other name: LE
intervention type: Procedure
intervention name: Total Mesorectal Excision
description: Standard TME surgery openly or laporoscopically
arm group label: Group C:Residual tumor
other name: TME
intervention type: Behavioral
intervention name: Quality of Life Questionnaires
description: QLQ C30 and QLQ CR29
arm group label: Group A:Clinical complete response (cCR)
arm group label: Group B:Near-cCR
arm group label: Group C:Residual tumor
other name: QLQ
FFPE and peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yiming Zhao, M.D.
phone: +8618600490721
phone ext: 18600490721
email: iammike0721@sina.com
last name: Aiwen Wu, M.D.
phone: +8613911577190
email: wuaw@hsc.pku.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Aiwen Wu
investigator title: Professor
mesh term: Rectal Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
sharing ipd: Undecided