drugset / Trial / NCT03301454
Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |