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.
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
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- 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
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.
oxaliplatinDrug
clinical observationOther
adjuvant therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Gemox 85 | Experimental | Adjuvant 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: | Other | Observation 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.
Disease-free survival
Measured: up to 3 years
Quality of life
Measured: up to 3 years
Secondary outcomes (2)
Overall survival
Measured: up to 3 years
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.
- First posted11 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eveline Boucher, MD, Principal investigator, Centre Eugene Marquis
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01313377
- Acronym / sponsor ID
- CDR0000696193
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: Gemox 85 | Experimental | Drug: gemcitabine hydrochloride, Drug: oxaliplatin, Procedure: adjuvant therapy, Procedure: quality-of-life assessmentAdjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85) |
| ARM B: | Other | Other: clinical observation, Procedure: quality-of-life assessmentObservation until progression or death |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochloride | Drug | ARM A: Gemox 85 |
| oxaliplatin | Drug | ARM A: Gemox 85 |
| clinical observation | Other | ARM B: |
| adjuvant therapy | Procedure or surgery | ARM A: Gemox 85 |
| quality-of-life assessment | Procedure or surgery | ARM A: Gemox 85, ARM B: |
Primary outcome
Disease-free survival
Time frame: up to 3 years
Quality of life
Time frame: up to 3 years
2 secondary outcomes
Overall survival
Time frame: up to 3 years
Toxicity of adjuvant chemotherapy
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eveline Boucher, MD principal investigator
Centre Eugene Marquis
37 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.