Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
Conditions
Squamous Cell Carcinoma of Esophagus
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
Chemotherapy, Best Supportive Care
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FU-CDDP Type: Drug
Name: LV5FU2-CDDP Type: Drug
Name: FOLFOX Type: Drug
Name: TPF Type: Drug
Name: Best Supportive Care Type: Other
Overall Status
Recruiting
Summary
Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.
Detailed Description
As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with an histologically proven epidermoid cancer of the oesophagus

- Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields

- Patients who may or may not have undergone radiochemotherapy

- Patients who have not received chemotherapy for metastatic disease

- ≥ 18 ans

- Performance Status (ECOG) ≤ 2

- People who are covered by private or state health insurance

- Informed consent signed by the patient

Exclusion Criteria:

- Other evolutive malignant tumor

- Infection with HIV-1, HIV-2 or chronic hepatitis B or C

- Cerebral metastasis or known meningeal tumor

- Any unstable chronic diseases that could risk the safety or the compliance of te patient

- Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab

- Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons

For the randomized part

Inclusion criteria :

- Non-progressive disease after the 6 first weeks of chemotherapy

- Performance Status (ECOG) ≤ 2
Locations
CHU Brest
Brest, France
Status: Recruiting
Contact: Jean-Philippe METGES, MD - +33(0)298223333 - jean-philippe.metges@chu-brest.fr
Centre François BACLESSE
Caen, France
Status: Recruiting
Contact: Marie-Pierre GALAIS, MD - +33(0)2 31 45 50 16 - mp.galais@baclesse.fr
Centre Georges François Leclerc
Dijon, France
Status: Recruiting
Contact: Francois GHIRINGHELLI, MD - fghiringhelli@dijon.fnclcc.fr
CHU Dijon
Dijon, France
Status: Recruiting
Contact: Laurent BEDENNE, MD, PhD - 03 80 29 37 50 - laurent.bedenne@chu-dijon.fr
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Antoine ADENIS, MD - +33(0)320295920 - a-adenis@o-lambret.fr
CHU Lille
Lille, France
Status: Recruiting
Contact: Mohammed HEBBAR, MD - +33(0)320445461 - m-hebbar@chru-lille.fr
CHU La Timone
Marseille, France
Status: Recruiting
Contact: Jean-François SEITZ, MD - jean-francois.seitz@ap-hm.fr
Centre Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Emmanuelle SAMALIN, MD - +33(0)467612592 - emmanuelle.samalin@valdorel.fnclcc.fr
Centre René Gauducheau
Nantes Saint-herblain, France
Status: Recruiting
Contact: Jaafar BENNOUNA - j-bennouna@nantes.fnclcc.fr
Centre Antoine Lacassagne
Nice, France
Status: Recruiting
Contact: Eric FRANCOIS, MD - +33(0)4 92 03 16 13 - eric.francois@nice.fnclcc.fr
Centre Eugène Marquis
Rennes, France
Status: Recruiting
Contact: Eveline BOUCHER, MD - +33(0)2 99 25 31 96 - boucher@rennes.fnclcc.fr
Clinique de la Theuillerie
Ris Orangis, France
Status: Recruiting
Contact: Linda BOUAITA, MD - 33 1 69 02 10 60 - linda.bouaita@yahoo.fr
CHU Rouen
Rouen, France
Status: Recruiting
Contact: Pierre MICHEL, MD, PhD - +33(0)232886450 poste 66456 - pierre.michel@chu-rouen.fr
Clinique de l'Armoricaine
St-Brieuc, France
Status: Recruiting
Contact: Pierre-Luc ETIENNE - +33(0)296752216 - aude.vincent@clin-armoricaine.fr
Centre Paul Strauss
Strasbourg, France
Status: Recruiting
Contact: Meher BEN ABDELGHANI, MD - 03 88 25 24 85 - mbenabdelghani@strasbourg.unicancer.fr
Centre Alexis Vautrin
Vandoeuvre-les-nancy, France
Status: Recruiting
Contact: Thierry CONROY, MD, PhD - +33(0)383598460 - t.conroy@nancy.fnclcc.fr
Centre Hospitalier Intercommunal
Villeneuve St Georges, France
Status: Recruiting
Contact: Linda BOUAITA, MD - 33 1 43 86 22 25 - linda.bouaita@yahoo.fr
Start Date
January 2011
Completion Date
September 2016
Sponsors
Centre Oscar Lambret
Source
Centre Oscar Lambret
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page