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AzTrials

Extrahepatic Bile Duct CancerPhase 2/3NCT00304135

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

A Phase 2/3 study testing cisplatin, gemcitabine hydrochloride and oxaliplatin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Federation Francophone de Cancerologie Digestive at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
cisplatin, gemcitabine hydrochloride and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
20 sitesFrance
Study dates
Oct 2005to Dec 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Centre Hospitalier General

    Belfort, 90000

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier de Dax

    Dax, 40100

  • Hopital Du Bocage

    Dijon, 21034

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • C. H. Du Mans

    Le Mans, 72037

  • CHU de la Timone

    Marseille, 13385

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Sebastopol, C.H.U. de Reims

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35062

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier de Semur en Auxois

    Semur-en-Auxois, 21140

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier de Tarbes

    Tarbes, 65013

Other trials in France

About this study

Official title: 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

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.

Read the 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.

Keywords
localized unresectable adult primary liver cancer, unresectable extrahepatic bile duct cancer, unresectable gallbladder cancer
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00304135
Study groupRoleWhat they receive
Radio-chimiothérapieActive comparatorRadio-chimiothérapie
Receives: Drug: cisplatin
GEMOXExperimentalGEMOX
Receives: Drug: gemcitabine hydrochloride; Drug: oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression rate at 3 months

    Measured: 2012

  2. Overall survival

    Measured: 2012

Secondary outcomes (2)

  1. Toxicity

    Measured: 2012

  2. Biliary complication rate

    Measured: 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00304135
Sponsor's protocol ID
CDR0000470411
Other IDs
FFCD-9902, SANOFI-FFCD-9902, LILLY-FFCD-9902, FFCD-FNCLCC-SFRO-9902
Status last verified
Dec 2006
First submitted
15 Mar 2006
Last updated
30 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25241229

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing cisplatin, gemcitabine hydrochloride and oxaliplatin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Federation Francophone de Cancerologie Digestive at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression rate at 3 months (time frame: 2012). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00304135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.

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