Esophageal Cancer, Squamous Cell Clinical Trial
Official title:
Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT
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
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:
- Arm A : pursuit of chemotherapy and best supportive care
- Arm B : interruption of chemotherapy and best supportive care
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03126708 -
Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma
|
Phase 2 |