Clinical trial · Interventional
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract
- 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)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer. PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radio-chimiothérapie
- description
- Radio-chimiothérapie
- interventionNames
- Drug: cisplatin
- type
- EXPERIMENTAL
- label
- GEMOX
- description
- GEMOX
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: oxaliplatin
Primary outcomes (2)
- measure
- Progression rate at 3 months
- timeFrame
- 2012
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer of the biliary tract by 1 of the following methods: * Histologic confirmation * Stenosis of the biliary tract by MRI, CT scan, or ECHO * Unresectable disease * Amenable to radiotherapy * No visceral metastases by imaging * Hepatic adenopathies that can be included in a radiation field allowed * No known ampulla of Vater or pancreatic cancer involving the biliary tract PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Creatinine \< 1.5 mg/dL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Prothrombin time \> 70% * Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed) * No unstable angina * No symptomatic cardiac insufficiency * No other comorbidity that would preclude study therapy * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No prior hydatid cyst or alveolar echinococciasis * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * No recent biliary surgery * No hepatic intra-arterial chemotherapy * No prior anticancer therapy
References
Publications (1)
- RESULTPhelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Federation Francophone de Cancerologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17. PMID 25241229