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

Phase 2TerminatedNCT01248299

Centre Oscar Lambret105 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Squamous Cell Carcinoma of Esophagus

Interventions

FU-CDDPDRUG

every 21 days: * Fluoro-uracil \[800 mg/m2, day 1 to day 5\] * CisPlatin \[75 mg/m2, day 1 or day 2\]

LV5FU2-CDDPDRUG

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 \[50 mg/m2, day 2\]

FOLFOXDRUG

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 \[500 mg/m2, day 1 and day 2\]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

CHU Brest

Brest, France

Centre François BACLESSE

Caen, France

Centre Georges François Leclerc

Dijon, France

Outcomes

Primary Outcomes

Overall survival

Time frame: Between the date of randomisation and the date of death

Secondary Outcomes

Progression free survival

Time frame: Between the date of randomisation and the date of progression

Tolerance

According to the NCI-CTCAE V4.0 grading scale

Time frame: 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

Time frame: 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

Time frame: Every 6 weeks

Data from ClinicalTrials.gov

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