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Extrahepatic Bile Duct CancerPhase 3NCT01313377

Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

A Phase 3 study testing gemcitabine hydrochloride, oxaliplatin and clinical observation in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by UNICANCER at 37 sites in France.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
gemcitabine hydrochloride, oxaliplatin and clinical observation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
37 sitesFrance
Study dates
Jul 2009to Jun 2016
Phase
Phase 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:

  • Histologically proven adenocarcinoma of the intrahepatic bile ducts, gallbladder, or extrahepatic bile ducts
  • Mixed forms of hepatocholangiocarcinomas included provided the cholangiocarcinoma is predominant
  • Underwent surgical resection of the disease (R0 or R1) at least 4 weeks but no more than 13 weeks ago
  • Nonmetastatic disease as assessed by abdominal MRI and chest x-ray
  • No cancer of the pancreas or duodenum invading the bile duct and ampulla of Vater

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine clearance > 40 mL/min
  • Prothrombin time > 60% OR INR < 1.5 (without anticoagulant therapy)
  • Transaminases ≤ 5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Conjugated bilirubin ≤ 35 μmol/L (after biliary drainage, if necessary)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to oxaliplatin and gemcitabine hydrochloride therapy
  • Prior invasive cancer allowed provided it has been in complete remission for ≥ 5 years
  • No other concurrent invasive cancer except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
  • No other severe, unresolved disease
  • No mental illness
  • No HIV positivity
  • No grade 1 angina or symptomatic angina ≥ grade 2
  • No sensitive peripheral neuropathy
  • No uncontrolled diabetes
  • No inability to undergo medical tests due to geographical, social, or psychological reasons
  • No prisoners or patients under guardianship
  • No Child B or C cirrhosis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior neoadjuvant chemotherapy or radiotherapy
  • No prior organ transplantation
  • No concurrent participation in another clinical trial of an experimental agent

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CHU - Hôpital Nord

    Amiens, 80054

  • Centre Paul Papin

    Angers, 49933

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre hospitalier de la Côte Basque

    Bayonne, 64109

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • CHU Brest - Hôpital Morvan

    Brest, 29200

  • CHU Côte de Nacre

    Caen, 14000

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hôpital Beaujon

    Clichy, 92118

  • Hôpital Henri Mondor

    Créteil, 94000

  • Hôpital Bocage

    Dijon, 21079

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Centre Léon Bérard

    Lyon, 69008

  • Hôpital Privé Jean Mermoz

    Lyon, 69373

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Hôpital Saint Joseph

    Marseille, 13008

  • Hôpital Nord

    Marseille, 13015

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU Timone Adulte

    Marseille, 13385

  • Centre Hospitalier Saint Eloi

    Montpellier, 34295

  • Centre René Gauducheau

    Nantes, 44805

  • Hôpital La Source

    Orléans, 45067

  • Hôpital Saint Antoine

    Paris, 75012

  • Institut Mutualiste Montsouris

    Paris, 75014

  • CHU Saint Louis

    Paris, 75475

  • Hôpital de la Pitié Salpétrière

    Paris, 75651

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • CHU de Rouen - Hôpital Ch. Nicolle

    Rouen, 76031

  • CHU Sainte-Etienne - Hopital Nord

    Saint-Étienne-d'Orthe, 42255

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hôpital de Hautepierre / Hôpital Civil

    Strasbourg, 67098

  • Hôpital Trousseau

    Tours, 37044

  • CHU Brabois

    Vandouevre Les Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare disease-free survival (DFS) of patients with resected biliary tract cancer treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical observation.
  • Compare quality of life of these patients.

Secondary

  • Compare overall survival of these patients.
  • Determine the toxicity of the chemotherapy in these patients.
  • Explore prognostic factors for DFS including resection result (R0 vs R1), location of primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and lymph node involvement (N0 vs N+ and Nx). (Exploratory)
  • Study pathological factors in surgical specimens to identify main characteristics and phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory)
  • Identify nontumor-associated liver injury and factors that may facilitate the emergence of biliary tract cancers. (Exploratory)
  • Identify signaling pathways that may predict response to therapy. (Exploratory)
  • Determine the molecular characteristics to differentiate tumors according to their position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma site [hilar], and peripheral cholangiocarcinoma vesicle site). (Exploratory)

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses.
  • Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits.

After completion of study therapy, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

Being tested
gemcitabine hydrochloride, oxaliplatin, clinical observation, adjuvant therapy, quality-of-life assessment
Keywords
adenocarcinoma of the extrahepatic bile duct, cholangiocarcinoma of the extrahepatic bile duct, liver and intrahepatic biliary tract cancer, localized extrahepatic bile duct cancer, adenocarcinoma of the gallbladder, cholangiocarcinoma of the gallbladder, localized gallbladder cancer
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

Study groups in NCT01313377
Study groupRoleWhat they receive
ARM A: Gemox 85ExperimentalAdjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
Receives: Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: quality-of-life assessment
ARM B:OtherObservation until progression or death
Receives: Other: clinical observation; Procedure: quality-of-life assessment

What is being measured

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

  1. Disease-free survival

    Measured: up to 3 years

  2. Quality of life

    Measured: up to 3 years

Secondary outcomes (2)

  1. Overall survival

    Measured: up to 3 years

  2. Toxicity of adjuvant chemotherapy

    Measured: up to 3 years

Timeline

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

  1. First posted11 Mar 2011 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2016
  4. Study completionJun 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313377
Sponsor's protocol ID
CDR0000696193
Other IDs
FRE-FNCLCC-ACCORD-18/0803, FRE-FNCLCC-PRODIGE-12, EUDRACT-2008-004560-39, EU-20982
Status last verified
Jan 2017
First submitted
10 Mar 2011
Last updated
25 Jan 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine hydrochloride, oxaliplatin and clinical observation in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by UNICANCER at 37 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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 phase mean?

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?

Disease-free survival (time frame: up to 3 years). 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 NCT01313377.

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 25 Jan 2017.

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