A Phase 2 interventional study of pursuit of chemotherapy in Esophageal Cancer, Squamous Cell, sponsored by Centre Oscar Lambret. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Treatment
Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :
Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.
Randomized phase:
Inclusion Criteria:
Inclusion Criteria for randomization:
Exclusion Criteria:
Pursuit of chemotherapy.
Drug: pursuit of chemotherapy
Interruption of chemotherapy, best supportive care
Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
Also known as: LV5FU2-paclitaxel CT
Estimate the overall survival for patients suffering from Esophageal cancer
Non-progressive disease at and after 6 weeks of treatment until progression
Time frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Estimate efficiency in term of overall survival, of pursuing chemotherapy
beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
Time frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the efficiency in term of progression-free of pursuing chemotherapy
beyond 6 weeks of treatment
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the rate of non progressive patients
after the 6 firsts weeks of treatment
Time frame: From date of inclusion until the date of the end the 6 firsts weeks of treatment
Estimate the overall survival of the whole study population
beyond the inclusion
Time frame: From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
Measure the toxicity of chemotherapy
during the initial treatment phase compared to the 2 treatment arms after randomization
Time frame: from baseline up to 12 months
Estimate the consequences of pursuing chemotherapy
beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
Plan to share: No
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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Esophageal Squamous Cell Carcinoma→
Centre Oscar Lambret