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A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course . (E-DIS)
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.
Details
| Lead sponsor | Centre Oscar Lambret |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 105 |
| Start date | 2011-01 |
| Completion | 2017-01 |
Conditions
- Squamous Cell Carcinoma of Esophagus
Interventions
- FU-CDDP
- LV5FU2-CDDP
- FOLFOX
- TPF
- Best Supportive Care
Primary outcomes
- Overall survival — Between the date of randomisation and the date of death
Countries
France