Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborator: National Cancer Institute, France
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Oxaliplatin

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