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 .
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Between the date of randomisation and the date of death
Antoine ADENIS, MD, PhD
Centre Oscar Lambret
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)