<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/NCT03307941</url>
  </required_header>
  <id_info>
    <org_study_id>IJB-GASTON-002-ARTEMIS-Eso</org_study_id>
    <secondary_id>2016-000935-42</secondary_id>
    <nct_id>NCT03307941</nct_id>
  </id_info>
  <brief_title>Assessment of Metabolic &amp; Path Response w/ RCT &amp; ImT Before Surgery in Locally Advanced Esoph and Gastro-esoph Jction CA</brief_title>
  <acronym>ARTEMIS-Eso</acronym>
  <official_title>Assessment of Metabolic and Pathological Response to Treatment With RCT and ImT Before Surgery in Locally Advanced Esophageal and Gastro-esophageal Junction Cancer: ARTemIS-Eso, a Three-level, Open-label, Phase I-II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jules Bordet Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innate Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jules Bordet Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at&#xD;
      recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma&#xD;
      and adenocarcinoma) of RCT and ImT administered prior to surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is indicated to patients with adenocarcinomas of the esophagus or&#xD;
      gastro-esophageal junction and squamous cell carcinoma of the esophagus.&#xD;
&#xD;
      The study consists of 2 parts:&#xD;
&#xD;
      Phase I of the study is composed of the 3 following levels, corresponding to changes in the&#xD;
      schedule and the number of administrations of monalizumab:&#xD;
&#xD;
      Level 1: monalizumab (ImT) administration starts 2 weeks after the end of RCT (Total of 3 ImT&#xD;
      doses). A maximum of 7 days delay is allowed.&#xD;
&#xD;
      Level 2: monalizumab administration starts directly at the end of RCT (Total of 4 ImT doses).&#xD;
      The first dose of monalizumab should be given on the following working day after the last&#xD;
      radiotherapy administration.&#xD;
&#xD;
      Level 3: monalizumab administration starts 2 weeks after the start of RCT (total of 6 ImT&#xD;
      doses). A maximum of 7 days delay is allowed.&#xD;
&#xD;
      Phase II (Expansion cohort): At the recommended level determined in phase I and according to&#xD;
      the number of patients already accrued, approximately 48-51 additional patients (half-SCC and&#xD;
      half-ADC) are included with the aim of assessing the activity of the recommended combination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Suspended collaboration with the company providing the study drug&#xD;
  </why_stopped>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</primary_completion_date>
  <phase>Phase 1/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>
  </study_design_info>
  <primary_outcome>
    <measure>Phase I: determine the feasibility to administer monalizumab</measure>
    <time_frame>From date of randomization until the date of first documented disease recurrence, assessed up to 28 months</time_frame>
    <description>Successful and safe administration of the combination of radio-chemotherapy and at least 2 doses of immunotherapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: pCR rate</measure>
    <time_frame>At date of surgery, assessed at 16 weeks post randomization</time_frame>
    <description>Defined by the absence of any tumoral cells on the surgical specimen post esophagectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase I: pCR rate</measure>
    <time_frame>At date of surgery, assessed at 16 weeks post randomization</time_frame>
    <description>Defined by the absence of any tumoral cells on the surgical specimen post esophagectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: DFS and OS at 2 years after surgery</measure>
    <time_frame>From date of randomization until the date of first documented event, assessed up to 28 months</time_frame>
    <description>DFS and OS at 2 years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase I: Human Anti-Human Antibodies against monalizumab (HAHA) in serum</measure>
    <time_frame>Week 5 to 3 months post surgery</time_frame>
    <description>Human Anti-Human Antibodies against monalizumab (HAHA) in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Two year-disease free survival (DFS) and two year-overall survival (OS)</measure>
    <time_frame>2 years after the date the last patient had his surgery provided the trial objectives have been met</time_frame>
    <description>Two year-disease free survival (DFS) and two year-overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Toxicity profile according to CTCAE v.4.03</measure>
    <time_frame>From date of randomization until the date of first documented event, assessed up to 28 months</time_frame>
    <description>Toxicity profile according to CTCAE v.4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Metabolic response after 1 course of CT and before surgery</measure>
    <time_frame>from week 1 up to the time of surgery</time_frame>
    <description>Metabolic response after 1 course of CT and before surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Number of the tumour-infiltrating lymphocytes (TILs)</measure>
    <time_frame>at baseline, after 1 course of CT at week 3 and after surgery at 16 weeks</time_frame>
    <description>Number of the tumour-infiltrating lymphocytes (TILs)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Adenocarcinoma of the Esophagus</condition>
  <condition>Adenocarcinoma of the Gastroesophageal Junction</condition>
  <condition>Squamous Cell Carcinoma of the Esophagus</condition>
  <arm_group>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Monalizumab</intervention_name>
    <description>Monalizumab (IPH2201) is given at the recommended dose of 10 mg/kg, intravenously (infusion during 60 minutes) every two weeks</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
    <other_name>IPH2201</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fluorouracil</intervention_name>
    <description>A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Metabolic</intervention_name>
    <description>Radiation therapy must start the first day of FOLFOX chemotherapy. Radiation is given once daily for 5 consecutive days; on the days that the patient receives chemotherapy (and monalizumab when applicable), chemotherapy (and monalizumab) should be given prior to radiotherapy.</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metabolic</intervention_name>
    <description>18-FDG-PET scan will be performed just before the beginning of radio-chemotherapy (D10-D14) and will be blinded for investigators and patients. Another 18-FDG-PET will be performed before surgery (surgery Day-5 to surgery Day -1) to exclude metastatic evolution</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
    <other_name>FDG-PET</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Surgery is performed preferably 8 weeks after the completion of the radio-chemotherapy, and it should not be performed less than one week after the last dose of monalizumab</description>
    <arm_group_label>Single arm (classic 3+3 design)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old&#xD;
&#xD;
          2. ECOG performance status ≤ 1&#xD;
&#xD;
          3. Female and Male&#xD;
&#xD;
          4. Must have histologically confirmed esophageal ADC or SCC or gastro-esophageal junction&#xD;
             ADC (Siewert I and II) eligible for a curative intent resection (recommended&#xD;
             exploration by EUS and diagnostic laparoscopy in gastro-esophageal junctions) without&#xD;
             restriction in age and sex and candidate for neoadjuvant RCT.&#xD;
&#xD;
          5. At least classified clinical T3Nx or any T, N+ according to cTNM version 7.&#xD;
&#xD;
          6. Negative serum pregnancy test (for women of childbearing potential) within 7 (+/-1)&#xD;
             days prior to the beginning of treatment.&#xD;
&#xD;
          7. Women of childbearing potential must agree to use one highly effective method of&#xD;
             contraception at study entry (if this is not already the case, put in place within 1&#xD;
             week after ICF signature, and at the very latest before 1st administration of study&#xD;
             treatment), during the study treatment administration and at least 5 months after the&#xD;
             last administration of study treatment.&#xD;
&#xD;
          8. Men must agree to use condom during the course of this study and for at least 5 months&#xD;
             after the last administration of the study treatment.&#xD;
&#xD;
          9. Adequate bone marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count ≥1500/µL or 1.5x109/L&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  Platelets ≥100000/µL or 100x109/L&#xD;
&#xD;
         10. Adequate liver function as defined below:&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome &lt; 3xUNL is&#xD;
                  allowed&#xD;
&#xD;
               -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN&#xD;
&#xD;
         11. Adequate renal function as defined:&#xD;
&#xD;
               -  Creatinine ≤ 1.5 x UNL or creatinine clearance &gt;60 mL/min&#xD;
&#xD;
         12. Participants must have normal cardiac and pulmonary functions defined with&#xD;
             ultrasonography (LVEF&gt;50%) and pulmonary function tests (including DLCO (diffusing&#xD;
             capacity factor of the lung for carbon monoxide)).&#xD;
&#xD;
         13. Completion of all necessary screening procedures within 28 days prior to enrolment.&#xD;
&#xD;
         14. Accessible tumour for biopsies through upper gastro-intestinal endoscopy (for&#xD;
             translational research activities).&#xD;
&#xD;
         15. Signed Informed Consent form (ICF) obtained prior to any study related procedure and&#xD;
             study treatment.&#xD;
&#xD;
         16. For the phase II expansion cohort only, significant FDG uptake at the primary tumour&#xD;
             on baseline PET/CT, performed not more than 7 days before the beginning of the first&#xD;
             course of CT, defined as SUVmax &gt; 2x the mean liver uptake.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting one of the following criteria are not eligible for this study:&#xD;
&#xD;
          1. Patient ineligible for curative intent surgery:&#xD;
&#xD;
               -  T4 with involvement of mediastinal structures as tracheobronchial, recurrent&#xD;
                  nerve, aorta over 90° of its circumference, vertebral body&#xD;
&#xD;
               -  Tumour ≥ 4cm in diameter developed above the carina&#xD;
&#xD;
               -  Visceral metastasis&#xD;
&#xD;
               -  Metastatic lymph nodes: supraclavicular and/or lombo-aortic&#xD;
&#xD;
               -  Cervical esophageal cancer defined as a tumor involving the lower border of the&#xD;
                  cricoid cartilage (at the level of the sixth cervical vertebra) to the thoracic&#xD;
                  inlet 5cm down under, generally between 18 and 20 cm from the dental arcade&#xD;
&#xD;
          2. Uncontrolled concurrent illness or any significant disease that, in the investigator's&#xD;
             opinion, would exclude the patient from the study.&#xD;
&#xD;
          3. Absolute contraindication for surgery: respiratory failure (VEMS &lt; 1000mL), weight&#xD;
             loss&gt; 20%, renal failure: creatinine &gt; 1.5 ULN, myocardial infarct &lt; 6 months,&#xD;
             evolutive cardiopathy, ECOG 3 and 4, non-compensated cirrhosis.&#xD;
&#xD;
          4. Pregnant and/or lactating women.&#xD;
&#xD;
          5. Uncontrolled diabetes.&#xD;
&#xD;
          6. Individuals with a history of a different malignancy within the last 5 years are&#xD;
             ineligible except cervical cancer in situ, and early stage basal cell or squamous cell&#xD;
             carcinoma of the skin.&#xD;
&#xD;
          7. Patients with active, known or suspected autoimmune disease or condition requiring&#xD;
             systemic treatment with either corticosteroids (&gt; 10 mg daily prednisone equivalents)&#xD;
             or other immunosuppressive systemic treatment.&#xD;
&#xD;
               -  (Exception: patients with vitiligo, type I diabetes mellitus, residual&#xD;
                  hypothyroidism due to autoimmune condition only requiring hormone replacement,&#xD;
                  psoriasis not requiring immunosuppressive systemic treatment, or conditions not&#xD;
                  expected to recur in the absence of an external trigger, are permitted to be&#xD;
                  enrolled.&#xD;
&#xD;
               -  Inhaled or topical steroids and adrenal replacement doses &gt; 10 mg daily&#xD;
                  prednisone equivalents are permitted in the absence of active/autoimmune disease.&#xD;
&#xD;
          8. Patients with diseases known for hypersensitivity to radiotherapy.&#xD;
&#xD;
          9. Prior treatment for esophageal cancer: surgery, radiotherapy, chemotherapy or&#xD;
             immunotherapy (in particular but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2,&#xD;
             anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell&#xD;
             co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumour&#xD;
             vaccines or other immuno-stimulatory anti-tumour agents.&#xD;
&#xD;
         10. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus&#xD;
             (ribonucleic acid or HCV antibody) indicating acute or chronic infection.&#xD;
&#xD;
         11. Positive test for human immunodeficiency virus (HIV) or known acquired&#xD;
             immunodeficiency syndrome (AIDS).&#xD;
&#xD;
         12. History of allergy to study drug components or excipients.&#xD;
&#xD;
         13. Subject with a significant medical, neuro-psychiatric, or surgical condition,&#xD;
             currently uncontrolled by treatment, which, in the principal investigator's opinion,&#xD;
             may interfere with completion of the study.&#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>Amelie Deleporte, Physician</last_name>
    <role>Study Chair</role>
    <affiliation>Jules Bordet Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_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/NCT03307941
org study id: IJB-GASTON-002-ARTEMIS-Eso
secondary id: 2016-000935-42
nct id: NCT03307941
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at
      recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma
      and adenocarcinoma) of RCT and ImT administered prior to surgery.
This study is indicated to patients with adenocarcinomas of the esophagus or
      gastro-esophageal junction and squamous cell carcinoma of the esophagus.

      The study consists of 2 parts:

      Phase I of the study is composed of the 3 following levels, corresponding to changes in the
      schedule and the number of administrations of monalizumab:

      Level 1: monalizumab (ImT) administration starts 2 weeks after the end of RCT (Total of 3 ImT
      doses). A maximum of 7 days delay is allowed.

      Level 2: monalizumab administration starts directly at the end of RCT (Total of 4 ImT doses).
      The first dose of monalizumab should be given on the following working day after the last
      radiotherapy administration.

      Level 3: monalizumab administration starts 2 weeks after the start of RCT (total of 6 ImT
      doses). A maximum of 7 days delay is allowed.

      Phase II (Expansion cohort): At the recommended level determined in phase I and according to
      the number of patients already accrued, approximately 48-51 additional patients (half-SCC and
      half-ADC) are included with the aim of assessing the activity of the recommended combination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase I: determine the feasibility to administer monalizumab
time frame: From date of randomization until the date of first documented disease recurrence, assessed up to 28 months
description: Successful and safe administration of the combination of radio-chemotherapy and at least 2 doses of immunotherapy
measure: Phase II: pCR rate
time frame: At date of surgery, assessed at 16 weeks post randomization
description: Defined by the absence of any tumoral cells on the surgical specimen post esophagectomy
measure: Phase I: pCR rate
time frame: At date of surgery, assessed at 16 weeks post randomization
description: Defined by the absence of any tumoral cells on the surgical specimen post esophagectomy
measure: Phase I: DFS and OS at 2 years after surgery
time frame: From date of randomization until the date of first documented event, assessed up to 28 months
description: DFS and OS at 2 years after surgery
measure: Phase I: Human Anti-Human Antibodies against monalizumab (HAHA) in serum
time frame: Week 5 to 3 months post surgery
description: Human Anti-Human Antibodies against monalizumab (HAHA) in serum
measure: Phase II: Two year-disease free survival (DFS) and two year-overall survival (OS)
time frame: 2 years after the date the last patient had his surgery provided the trial objectives have been met
description: Two year-disease free survival (DFS) and two year-overall survival (OS)
measure: Phase II: Toxicity profile according to CTCAE v.4.03
time frame: From date of randomization until the date of first documented event, assessed up to 28 months
description: Toxicity profile according to CTCAE v.4.03
measure: Phase II: Metabolic response after 1 course of CT and before surgery
time frame: from week 1 up to the time of surgery
description: Metabolic response after 1 course of CT and before surgery
measure: Phase II: Number of the tumour-infiltrating lymphocytes (TILs)
time frame: at baseline, after 1 course of CT at week 3 and after surgery at 16 weeks
description: Number of the tumour-infiltrating lymphocytes (TILs)
arm group label: Single arm (classic 3+3 design)
arm group type: Other
intervention type: Drug
intervention name: Monalizumab
description: Monalizumab (IPH2201) is given at the recommended dose of 10 mg/kg, intravenously (infusion during 60 minutes) every two weeks
arm group label: Single arm (classic 3+3 design)
other name: IPH2201
intervention type: Drug
intervention name: Oxaliplatin
description: A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
arm group label: Single arm (classic 3+3 design)
intervention type: Drug
intervention name: 5-Fluorouracil
description: A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
arm group label: Single arm (classic 3+3 design)
intervention type: Radiation
intervention name: Metabolic
description: Radiation therapy must start the first day of FOLFOX chemotherapy. Radiation is given once daily for 5 consecutive days; on the days that the patient receives chemotherapy (and monalizumab when applicable), chemotherapy (and monalizumab) should be given prior to radiotherapy.
arm group label: Single arm (classic 3+3 design)
intervention type: Other
intervention name: Metabolic
description: 18-FDG-PET scan will be performed just before the beginning of radio-chemotherapy (D10-D14) and will be blinded for investigators and patients. Another 18-FDG-PET will be performed before surgery (surgery Day-5 to surgery Day -1) to exclude metastatic evolution
arm group label: Single arm (classic 3+3 design)
other name: FDG-PET
intervention type: Procedure
intervention name: Surgery
description: Surgery is performed preferably 8 weeks after the completion of the radio-chemotherapy, and it should not be performed less than one week after the last dose of monalizumab
arm group label: Single arm (classic 3+3 design)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amelie Deleporte, Physician
role: Study Chair
affiliation: Jules Bordet Institute
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Fluorouracil
mesh term: Oxaliplatin
sharing ipd: No