<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/NCT03283761</url>
  </required_header>
  <id_info>
    <org_study_id>BTCRC-GI15-015</org_study_id>
    <nct_id>NCT03283761</nct_id>
  </id_info>
  <brief_title>FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma</brief_title>
  <official_title>A Phase II Study of FOLFOX Combined With Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma. Big Ten Cancer Research Consortium: BTCRC-GI15-015</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al B. Benson, III, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Big Ten Cancer Research Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Big Ten Cancer Research Consortium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, single-arm phase II, multi-institutional trial to evaluate the&#xD;
      efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line&#xD;
      therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ&#xD;
      adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days).&#xD;
      Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by&#xD;
      oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV&#xD;
      infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic&#xD;
      assessment will be performed at baseline and every other cycle (starting with Cycle 3) to&#xD;
      evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to&#xD;
      receive treatment until disease progression or unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open-Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Objective Response Rate</measure>
    <time_frame>2 years</time_frame>
    <description>partial or complete response of FOLFOX combined with nab-paclitaxel (FOLFOX-A) in patients with advanced gastric, gastroesophageal junction adenocarcinoma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP)</measure>
    <time_frame>2 years</time_frame>
    <description>will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Rate (ORR)</measure>
    <time_frame>2 years</time_frame>
    <description>will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Disease Control Rate (DCR)</measure>
    <time_frame>2 years</time_frame>
    <description>will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>grade 3 and 4 adverse events defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Gastro-Esophageal Junction Adenocarcinoma</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel 150 mg/m^2</intervention_name>
    <description>Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Abraxane®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin 85 mg/m^2</intervention_name>
    <description>Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-FU 1200 mg/m^2 x 2 D</intervention_name>
    <description>Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Adrucil</other_name>
    <other_name>Fluorouracil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leucovorin 400 mg/m^2</intervention_name>
    <description>Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subject must meet all of the following applicable inclusion criteria to participate in this&#xD;
        study:&#xD;
&#xD;
          -  Written informed consent and HIPAA authorization for release of personal health&#xD;
             information. NOTE: HIPAA authorization may be included in the informed consent or&#xD;
             obtained separately.&#xD;
&#xD;
          -  Age ≥ 18 years at the time of consent.&#xD;
&#xD;
          -  ECOG Performance Status of 0-1 within 28 days prior to registration.&#xD;
&#xD;
          -  Histologically-confirmed advanced or metastatic unresectable gastric carcinoma, or&#xD;
             adenocarcinoma of the gastroesophageal junction.&#xD;
&#xD;
          -  Prior neoadjuvant or adjuvant chemotherapy, hormonal therapy, immunotherapy, radiation&#xD;
             or chemoradiotherapy must have been completed at least 6 months prior to documented&#xD;
             recurrence or metastatic disease. NOTE: patients must not have received previous&#xD;
             systemic treatment for metastatic disease.&#xD;
&#xD;
          -  Evaluable disease according to RECIST v1.1 for solid tumors, within 28 days prior to&#xD;
             registration.&#xD;
&#xD;
          -  Demonstrate adequate organ function as described below; all screening labs to be&#xD;
             obtained within 28 days prior to registration.&#xD;
&#xD;
               -  Bilirubin &lt; 1.5 mg/dL&#xD;
&#xD;
               -  Patients must have adequate liver function: AST and ALT &lt; 2.5 x upper limit of&#xD;
                  normal, alkaline phosphatase &lt; 2.5 x upper limit of normal, unless bone or liver&#xD;
                  metastasis is present (≤5 x upper limit of normal).&#xD;
&#xD;
               -  Patients must have adequate bone marrow function: Platelets &gt;100,000 cells/mm3&#xD;
                  (transfusion independent, defined as not receiving platelet transfusions within 7&#xD;
                  days prior to laboratory sample), Hemoglobin &gt; 9.0g/dL and ANC &gt; 1,500 cells/mm3.&#xD;
&#xD;
               -  Patients must have adequate renal function: creatinine &lt;1.5 mg/dL or creatinine&#xD;
                  clearance ≥60mL/min is recommended; however, institutional norms are acceptable.&#xD;
&#xD;
          -  Females of child-bearing potential (defined as a sexually mature woman who (1) has not&#xD;
             undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy&#xD;
             [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal&#xD;
             for at least 24 consecutive months [i.e., has had menses at any time during the&#xD;
             preceding 24 consecutive months]) must:&#xD;
&#xD;
               -  Either commit to true abstinence* from heterosexual contact (which must be&#xD;
                  reviewed on a monthly basis), or agree to use and be able to comply with&#xD;
                  effective contraception without interruption 28 days prior to starting&#xD;
                  investigational product (IP), and while on study medication (including dose&#xD;
                  interruptions) and for 30 days following the last dose of IP; and&#xD;
&#xD;
               -  Have a negative serum pregnancy test (β -hCG) result at screening and agree to&#xD;
                  ongoing pregnancy testing prior to each treatment and after the end of study&#xD;
                  therapy. This applies even if the subject practices true abstinence* from&#xD;
                  heterosexual contact.&#xD;
&#xD;
               -  Male subjects must practice true abstinence* or agree to use a condom during&#xD;
                  sexual contact with a pregnant female or a female of childbearing potential while&#xD;
                  participating in the study, during dose interruptions and for 6 months following&#xD;
                  IP discontinuation, even if he has undergone a successful vasectomy.&#xD;
&#xD;
                    -  NOTE: True abstinence is acceptable when this is in line with the preferred&#xD;
                       and usual lifestyle of the subject. [Periodic abstinence (eg, calendar,&#xD;
                       ovulation, symptothermal, post-ovulation methods) and withdrawal are not&#xD;
                       acceptable methods of contraception].&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects meeting any of the criteria below may not participate in the study:&#xD;
&#xD;
          -  Her-2 positive gastric tumor.&#xD;
&#xD;
          -  Treatment with any investigational products within 28 days prior to study&#xD;
             registration.&#xD;
&#xD;
          -  Preexisting peripheral neuropathy is not allowed from any cause.&#xD;
&#xD;
          -  Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing&#xD;
             is not required).&#xD;
&#xD;
          -  Patients with active sepsis or pneumonitis&#xD;
&#xD;
          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.&#xD;
             Subjects with previously treated brain metastases may participate provided they are&#xD;
             stable (without evidence of progression by imaging for at least four weeks prior to&#xD;
             trial registration and any neurologic symptoms have returned to baseline), have no&#xD;
             evidence of new or enlarging brain metastases, and are not using steroids for at least&#xD;
             7 days prior to trial registration.&#xD;
&#xD;
          -  Known hypersensitivity to fluorouracil (5-FU), oxaliplatin, or other platinum agents.&#xD;
&#xD;
          -  Known hypersensitivity to nab-paclitaxel or any of its excipients.&#xD;
&#xD;
          -  History of slowly progressive dyspnea and unproductive cough, or pulmonary conditions&#xD;
             such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, hypersensitivity&#xD;
             pneumonitis or multiple allergies. See section 6.5.1.&#xD;
&#xD;
          -  Has known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not&#xD;
             required)&#xD;
&#xD;
          -  Ongoing or active infection requiring systemic treatment (must be afebrile for ≥ 48&#xD;
             hours prior to study registration)&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to any of the following:&#xD;
&#xD;
               -  Symptomatic congestive heart failure&#xD;
&#xD;
               -  Unstable angina pectoris&#xD;
&#xD;
               -  Cardiac arrhythmia&#xD;
&#xD;
          -  Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the&#xD;
             mother is being treated on study).&#xD;
&#xD;
          -  Known additional malignancy within the past 3 years. Exceptions include treated&#xD;
             localized basal cell or squamous cell carcinoma of the skin, in situ cervical or&#xD;
             vulvar carcinoma that has undergone potentially curative therapy, superficial bladder&#xD;
             tumors (Ta, Tis &amp; T1), ductal carcinoma in situ (DCIS) of the breast and low grade&#xD;
             prostate cancer (Gleason sore 6). Any cancer curatively treated &gt; 3 years prior to&#xD;
             registration with no clinical evidence of recurrence is permitted.&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Any other illness or condition that the treating investigator feels would interfere&#xD;
             with study compliance or would compromise the patient's safety or study endpoints&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Al B. Benson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Big Ten Cancer Research Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univeristy of Illinois Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Lake Forest Hospital</name>
      <address>
        <city>Lake Forest</city>
        <state>Illinois</state>
        <zip>60045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bigtencrc.org</url>
    <description>Big Ten Cancer Research Consortium Website</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Big Ten Cancer Research Consortium</investigator_affiliation>
    <investigator_full_name>Al B. Benson, III, MD</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>FOLFOX</keyword>
  <keyword>Nab-Paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Fluorouracil</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/NCT03283761
org study id: BTCRC-GI15-015
nct id: NCT03283761
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open label, single-arm phase II, multi-institutional trial to evaluate the
      efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line
      therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ
      adenocarcinoma.
All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days).
      Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by
      oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV
      infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic
      assessment will be performed at baseline and every other cycle (starting with Cycle 3) to
      evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to
      receive treatment until disease progression or unacceptable toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-Label
measure: Overall Objective Response Rate
time frame: 2 years
description: partial or complete response of FOLFOX combined with nab-paclitaxel (FOLFOX-A) in patients with advanced gastric, gastroesophageal junction adenocarcinoma
measure: Overall Survival (OS)
time frame: 2 years
description: will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
measure: Progression-Free Survival (PFS)
time frame: 2 years
description: will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
measure: Time to Progression (TTP)
time frame: 2 years
description: will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
measure: Best Overall Response Rate (ORR)
time frame: 2 years
description: will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test
measure: Best Disease Control Rate (DCR)
time frame: 2 years
description: will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test
measure: Adverse Events
time frame: 2 years
description: grade 3 and 4 adverse events defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4
arm group label: Treatment Arm
arm group type: Experimental
description: All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Nab-paclitaxel 150 mg/m^2
description: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
arm group label: Treatment Arm
other name: Abraxane®
intervention type: Drug
intervention name: Oxaliplatin 85 mg/m^2
description: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
arm group label: Treatment Arm
other name: Eloxatin
intervention type: Drug
intervention name: 5-FU 1200 mg/m^2 x 2 D
description: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16
arm group label: Treatment Arm
other name: Adrucil
other name: Fluorouracil
intervention type: Drug
intervention name: Leucovorin 400 mg/m^2
description: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Al B. Benson, MD
role: Principal Investigator
affiliation: Big Ten Cancer Research Consortium
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.bigtencrc.org
description: Big Ten Cancer Research Consortium Website
responsible party type: Sponsor-Investigator
investigator affiliation: Big Ten Cancer Research Consortium
investigator full name: Al B. Benson, III, MD
investigator title: Sponsor-Investigator
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Leucovorin
mesh term: Paclitaxel
mesh term: Fluorouracil
mesh term: Oxaliplatin
sharing ipd: Undecided