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 .
18 Years
N/A
Both
Squamous Cell Carcinoma of Esophagus
Trial Information
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
radiochemotherapy.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Between the date of randomisation and the date of death
Safety Issue:
No
Principal Investigator
Antoine ADENIS, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
E-DIS 2010-06
NCT ID:
NCT01248299
Start Date:
January 2011
Completion Date:
June 2014
Related Keywords:
- Squamous Cell Carcinoma of Esophagus
- Chemotherapy
- Best Supportive Care
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
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