Overview

This trial is active, not recruiting.

Condition squamous cell carcinoma of esophagus
Treatments fu-cddp, lv5fu2-cddp, folfox, tpf, best supportive care
Phase phase 2
Sponsor Centre Oscar Lambret
Collaborator National Cancer Institute, France
Start date January 2011
End date January 2015
Trial size 105 participants
Trial identifier NCT01248299, 2010-021439-16, E-DIS 2010-06

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
fu-cddp Fluoro-uracil+CisPlatin
every 21 days: Fluoro-uracil [800 mg/m2, day 1 to day 5] CisPlatin [75 mg/m2, day 1 or day 2]
lv5fu2-cddp Elvorin+Fluoro-uracil+CisPlatin
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]
folfox Oxaliplatin+Fluoro-uracil+Elvorin
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]
tpf Docetaxel+CisPlatine+Fluoro-uracile
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]
(Active Comparator)
Best supportive care with follow up every 6 weeks
best supportive care antalgic treatment, nutritional support, ...
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Primary Outcomes

Measure
Overall survival
time frame: Between the date of randomisation and the date of death

Secondary Outcomes

Measure
Progression free survival
time frame: Between the date of randomisation and the date of progression
Tolerance
time frame: At each visit : every 6 weeks
Quality of life
time frame: Every 6 weeks
Cost analysis
time frame: Every 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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 .
Principal investigator Antoine ADENIS, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.