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mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03464968
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Won Kim, Seoul National University Bundang Hospital

Brief Summary:
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.

Condition or disease Intervention/treatment Phase
Biliary Cancer Metastatic Drug: Oxaliplatin,5FU, leucovorin Drug: irinotecan,5FU, leucovorin Phase 2

Detailed Description:
  1. brief enrollment criteria

    • histological confirmed
    • refractory to first line gemcitabine plus cisplatin
    • fit for chemotherapy
  2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

    B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

  3. randomization - stratified by tumor site and performance status

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin
Actual Study Start Date : July 29, 2015
Estimated Primary Completion Date : December 25, 2019
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Leucovorin

Arm Intervention/treatment
Experimental: mFOLFOX
D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Drug: Oxaliplatin,5FU, leucovorin
mFOLFOX

Experimental: mFOLFIRI
D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Drug: irinotecan,5FU, leucovorin
mFOLFIRI




Primary Outcome Measures :
  1. 6 months overall survival rate [ Time Frame: 6months ]
    at 6 months from intervention treatment, overall survival rate


Secondary Outcome Measures :
  1. response rate [ Time Frame: 6months ]
    complete response, partial response

  2. disease control rate [ Time Frame: 6months ]
    complete response, partial response, stable disease

  3. progression free survival [ Time Frame: 6months ]
    from treatment start to progression or any cause of death

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0 [ Time Frame: 6months ]
    percentage of all patients



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 years and older
  • pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
  • initially inoperable or recurrent
  • ECOG 0-2
  • as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
  • evaluable or measurable lesion
  • within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
  • patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage

Exclusion Criteria:

  • other cancer history
  • pregnant or lactating
  • uncontrolled medical condition such as infection or cardiovascular disease
  • hypersensitivity to experimental drugs
  • uncontrolled CNS metastasis, psychologic problem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464968


Contacts
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Contact: Jin Won Kim, MD, PhD 82 031 787 7053 jwkim@snubh.org

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13620
Contact: Jin Won Kim, MD, PhD    82-31-787-8209    jwkim@snubh.org   
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Responsible Party: Jin Won Kim, Clinical Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03464968    
Other Study ID Numbers: biliary second line
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin Won Kim, Seoul National University Bundang Hospital:
second line
FOLFOX
FOLFIRI
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Leucovorin
Oxaliplatin
Irinotecan
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors