Last updated on August 2018

Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer

Brief description of study

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 :

  • non randomized phase in which all patients will undergo chemotherapy
  • second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study

Detailed Study Description

Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m - 5-FU continuously during 46h: 3000 mg/m, calcium levofolinate 200 mg/m) - paclitaxel (100 mg/m 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:

  • Arm A : pursuit of chemotherapy and best supportive care
  • Arm B : interruption of chemotherapy and best supportive care

Clinical Study Identifier: NCT03301454

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Recruitment Status: Open

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