Status:
TERMINATED
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Squamous Cell Carcinoma of Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01248299
Start Date
January 1 2011
End Date
January 1 2017
Last Update
May 16 2019
Active Locations (17)
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1
CHU Brest
Brest, France, 29200
2
Centre François BACLESSE
Caen, France, 14076
3
Centre Georges François Leclerc
Dijon, France, 21079
4
CHU Dijon
Dijon, France, 21079