Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patient… (NCT00304135) | Clinical Trial Compass
CompletedPhase 2/3
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
France34 participantsStarted 2005-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression rate at 3 months
Timeframe: 2012
2
Overall survival
Timeframe: 2012
Trial details
NCT IDNCT00304135
SponsorFederation Francophone de Cancerologie Digestive