mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line
- Conditions
- Biliary Cancer Metastatic
- Interventions
- Drug: Oxaliplatin, 5FU, leucovorinDrug: Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,
- Registration Number
- NCT07062536
- Lead Sponsor
- 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/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.
- Detailed Description
1. brief enrollment criteria
* histological confirmed
* refractory to first line gemcitabine plus cisplatin
* fit for chemotherapy
2. treatment arm A. mFOLFOX (Administered as a single regimen every 2weeks) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr
treatment arm B. mFOLFOX/mFOLFIRI (Administered alternately every 2 weeks.) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr 2) mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr
3. randomization - stratified by site and performance status
* Previous cancer treatment (including IO agents vs. excluding IO agents)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mFOLFOX Oxaliplatin, 5FU, leucovorin 1) mFOLFOX (Administered as a single regimen every 2weeks) D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr mFOLFOX/mFOLFIRI Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin, (Administered alternately every 2 weeks.) 1. mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr 2. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr
- Primary Outcome Measures
Name Time Method 6months overall survival rate 6months at 6months from intervention treatment, overall survival rate
- Secondary Outcome Measures
Name Time Method response rate 6months complete response,partial response
disease control rate 6month complete response, partial response, stable disease
progression free survival 6month 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 6month percentage of all patients
Trial Locations
- Locations (1)
Jin Won Kim
🇰🇷Seongnam-si,, Out Of US, Korea, Republic of
Jin Won Kim🇰🇷Seongnam-si,, Out Of US, Korea, Republic of