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

Centre Oscar Lambret

Status and phase: Terminated; Phase 2

Conditions: Squamous Cell Carcinoma of Esophagus

Treatments: Other: Best Supportive Care; Drug: LV5FU2-CDDP; Drug: FOLFOX; Drug: TPF; Drug: FU-CDDP

Study type: Interventional

Funder types: Other

Identifiers

NCT01248299

2010-021439-16 (Other Identifier)

E-DIS 2010-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Chemotherapy plus best supportive care

Experimental group

Description:

Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF

Treatment:

Drug: FOLFOX

Drug: LV5FU2-CDDP

Drug: TPF

Drug: FU-CDDP

Best supportive care

Active Comparator group

Description:

Best supportive care with follow up every 6 weeks

Treatment:

Other: Best Supportive Care