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NCT00304135 · CITED IN SOURCE DOCUMENTS

Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2016-05-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Radio-chimiothérapie
    intervention Names
    1. Drug: cisplatin
    label
    Radio-chimiothérapie
    type
    ACTIVE_COMPARATOR
  2. description
    GEMOX
    intervention Names
    1. Drug: gemcitabine hydrochloride
    2. Drug: oxaliplatin
    label
    GEMOX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Radio-chimiothérapie
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. GEMOX
    name
    gemcitabine hydrochloride
    type
    DRUG
  3. arm Group Labels
    1. GEMOX
    name
    oxaliplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
34
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression rate at 3 months
    time Frame
    2012
  2. measure
    Overall survival
    time Frame
    2012
secondary Outcomes
  1. measure
    Toxicity
    time Frame
    2012
  2. measure
    Biliary complication rate
    time Frame
    2012
Full study description
brief 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.
detailed Description
OBJECTIVES: Primary * Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and oxaliplatin. (phase II) * Compare the overall survival of patients treated with these regimens. (phase III) Secondary * Compare toxicities of these regimens in these patients. (phase II) * Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens. * Compare the biliary complication rate in patients treated with these regimens. * Compare the duration of hospitalization of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months thereafter. After completion of study therapy, patients are followed periodically for 2 years. PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.
Source references
references
  1. citation
    Phelip 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
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        vation, but both studies were closed early because of poor accrual.</p> <div class="pdq-content-list"><ol id="_450"><li> The <a href="/clinicaltrials/NCT00304135">FFCD-9902</a> trial (NCT00304135) randomly assigned 173 patients (200 patients were planned) to postoperative 5-FU/LV, which is the Mayo Clinic regimen, or o
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        ed early because of poor accrual.</p> <div class="pdq-content-list"><ol id="_450"><li> The <a href="/clinicaltrials/NCT00304135">FFCD-9902</a> trial (NCT00304135) randomly assigned 173 patients (200 patients were planned) to postoperative 5-FU/LV, which is the Mayo Clinic regimen, or observation.[<a href="#cit/section_
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      source title
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      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice