Clinical trial · Interventional
Salvage mFOLFOX in BTC After Failure of Gemcitabine
Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine
NCT01127555CI-TRIAL-00012343completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil, leucovorin, oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 1 year
- description
- Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
Secondary outcomes (3)
- measure
- To evaluate the safety
- timeFrame
- 1 year
- description
- Clinically assessed every cycle (2weeks)
- measure
- To estimate the time to progression
- timeFrame
- 1 year
- measure
- To estimate overall survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age : older than 18 2. Histologically confirmed adenocarcinoma of the biliary tract 3. Metastatic or unresectable biliary cancer 4. Prior exposure to gemcitabine chemotherapy for biliary cancer 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 6. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT 7. Adequate bone marrow, liver, renal function Exclusion Criteria: 1. Pregnancy and breast-feeding. 2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics). 3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. 4. Symptomatic or uncontrolled brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.