NCT01248299

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

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 .

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of Esophagus

Interventions

Type	Name	Description
DRUG	FU-CDDP	every 21 days: * Fluoro-uracil \[800 mg/m2, day 1 to day 5\] * CisPlatin \[75 mg/m2, day 1 or day 2\]
DRUG	LV5FU2-CDDP	every 14 days: * Elvorin \[200 mg/m2, 2h IV, day 1 and day 2\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, 22h continous infusion, day 1 and day 2\] * CisPlatin \[50 mg/m2, day 2\]
DRUG	FOLFOX	every 14 days: * Oxaliplatin \[85 mg/m2 by 2h infusion, day 1\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, by 22h continous infusion, day 1 and day 2\] * Elvorin \[500 mg/m2, day 1 and day 2\]
DRUG	TPF	every 21 days: * Docetaxel \[30 mg/m2, day 1 and day 8\] * CisPlatin \[60 mg/m2, day 1\] * Fluoro-uracil \[200 mg/m2/day by continous infusion\] Or every 21 days: * Docetaxel \[50 mg/m2, day 1\] * CisPlatine \[70 mg/m2, day 1\] * Fluoro-uracile \[700 mg/m2 /day, day 1 to day 5\]
OTHER	Best Supportive Care	See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2010-11-25
• Last updated: 2019-05-16

Locations

17 sites across 1 country: France