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Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

NCT02591030 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2022-02-24

No results posted yet for this study

Summary

Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their therapeutic management is complex and must be multidisciplinary in nature. Most of the time, an endoscopic or radiological biliary drainage is necessary before any tumour treatment.

Their prognosis is poor due to the fact that they are normally diagnosed late, which makes curative surgery impossible. A population study in the Côte d'Or region of France reported a survival rate at 5 years of approximately 10%.

For the locally advanced or metastatic forms, treatment has not been properly codified. With respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour (bile duct and pancreas tumours). Treatment with 5FU alone provides an objective response in approximately 10% of cases. In combination with mitomycin or carboplatin, the objective response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU has a better response rate (30%), but occurrences of different types of toxicity are more frequent.

More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50% of patients with a median survival period of 10 months. Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months.

The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced unresectable and/or metastatic bile duct cancer. The results were in favour of the combined treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 \[0.52 - 0.80\]). This combination is currently the reference first-line treatment.

Conditions

Interventions

DRUG

GEMCIS

At D1 and D8 of each cycle, i.e. every 21 days for 6 months: * Cisplatin 25 mg/m² over 1 hour at D1 and D8 * Gemcitabine 1000 mg/m² over 30 minutes at D1 and D8.

DRUG

mFolfirinox

At D1 of each cycle, i.e. every 15 days for 6 months: * Oxiplatin: 85 mg/m² (IP/120 minutes) * Irinotecan: 180 mg/m² (IV/90 minutes) * Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine \[calcium levofolinate\]) (IV/2 hours), via a Y connector at the same time as irinotecan * 5-FU: 2400 mg/m² (IV over 46 hours) without 5FU bolus at D1

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Jean-Marc Phelip, PhD · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2018-06-27
Completion
2020-01-16

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591030 on ClinicalTrials.gov