drugset / Trial / NCT02359968

PReoperative Chemoradiation (Paclitaxel-carboplatin or FOLFOX) for Resectable Esophageal and Junctional Cancer

NCT02359968 ↗

RandomizedFactorialOpen-labelTreatment

Summary

Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy treatment is the FOLFOX. It is a combination of three drugs administered intravenously: fluorouracil, oxaliplatin and folinic acid. This is the standard treatment. Another protocol of chemotherapy is widely used by certain European and American teams, due to promising results : a combination of two drugs administered intravenously: Paclitaxel and Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one treatment over the other. The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments.

Timeline

Start
2015-02-26
Primary completion
2021-01-08
Completion
2024-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2 unknown Intravenous
Comparator Leucovorin Small molecule 200 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 50 mg/m2 Intravenous
Comparator fluorouracil Small molecule 1600 mg/m2 Intravenous