drugset / Trial / NCT03301454

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

NCT03301454

Phase 2 Terminated 15 enrolled Centre Oscar Lambret
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2018-08-20
Primary completion
2022-07-05
Completion
2022-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Levoleucovorin Unknown 200 mg/m2
Subject Paclitaxel Small molecule 100 mg/m2
Subject fluorouracil Small molecule 400 mg/m2
Subject fluorouracil Small molecule 3000 mg/m2
Background Chlorpheniramine Unknown
Background Dexamethasone Small molecule
Background Ranitidine Unknown