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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03464968 |
Recruitment Status :
Completed
First Posted : March 14, 2018
Last Update Posted : December 2, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Biliary Cancer Metastatic | Drug: Oxaliplatin,5FU, leucovorin Drug: irinotecan,5FU, leucovorin | Phase 2 |
-
brief enrollment criteria
- histological confirmed
- refractory to first line gemcitabine plus cisplatin
- fit for chemotherapy
-
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
- randomization - stratified by tumor site and performance status
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 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 |
Actual Primary Completion Date : | February 10, 2020 |
Actual Study Completion Date : | July 25, 2020 |
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 |
- 6 months overall survival rate [ Time Frame: 6months ]at 6 months from intervention treatment, overall survival rate
- response rate [ Time Frame: 6months ]complete response, partial response
- disease control rate [ Time Frame: 6months ]complete response, partial response, stable disease
- progression free survival [ Time Frame: 6months ]from treatment start to progression or any cause of death
- Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0 [ Time Frame: 6months ]percentage of all patients
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Korea, Republic of | |
Seoul National University Bundang Hospital | |
Seongnam, Gyeonggi, Korea, Republic of, 13620 |
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: | December 2, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
second line FOLFOX FOLFIRI |
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 Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |