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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 .

Conditions
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Squamous Cell Carcinoma of Esophagus

Intervention / Treatment
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* Drug: FU-CDDP
* Drug: LV5FU2-CDDP
* Drug: FOLFOX
* Drug: TPF
* Other: Best Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy plus best supportive care<br>Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF | Drug: FU-CDDP<br>* every 21 days: Fluoro-uracil [800 mg/m2, day 1 to day 5] CisPlatin [75 mg/m2, day 1 or day 2]<br>* Other names: Fluoro-uracil+CisPlatin;Drug: LV5FU2-CDDP<br>* 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]<br>* Other names: Elvorin+Fluoro-uracil+CisPlatin;Drug: FOLFOX<br>* 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]<br>* Other names: Oxaliplatin+Fluoro-uracil+Elvorin;Drug: TPF<br>* 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]<br>* Other names: Docetaxel+CisPlatine+Fluoro-uracile;|
| Active Comparator: Best supportive care<br>Best supportive care with follow up every 6 weeks | Other: Best Supportive Care<br>* See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...<br>* Other names: antalgic treatment, nutritional support, ...;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Between the date of randomisation and the date of death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Between the date of randomisation and the date of progression | 
| Tolerance | According to the NCI-CTCAE V4.0 grading scale | At each visit : every 6 weeks | 
| Quality of life by QLQ-C30 | EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire | Every 6 weeks | 
| Cost analysis | Data collected : Hospitalization day hospital visit Chemotherapy drugs administered Home medical care Radiotherapy Oncologist visits, General Practitioner Visits Laboratory and radiologic tests | Every 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Best Supportive Care