Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus
- Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with
or without paclitaxel in terms of survival without dysphagia in patients with
inoperable stage II or III epidermoid carcinoma of the esophagus.
- Compare the overall survival, response rate, toxicity, and quality of life in this
patient population treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to weight loss (less than 10% vs at least 10%) and inoperability criteria
(nonresectable vs due to anatomical terrain). Patients are randomized to one of two
- Arm I: Patients receive fluorouracil IV continuously, oral hydroxyurea, and concurrent
radiotherapy daily on days 1-5.
- Arm II: Patients receive fluorouracil, hydroxyurea and radiotherapy as in arm I.
Patients also receive paclitaxel IV on day 1.
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or
Patients with possible resectable disease undergo surgical resection at 4-6 weeks following
the last course of chemoradiotherapy. Patients with continued unresectable disease receive 2
additional courses of chemoradiotherapy as above within 8-17 days following the last course
Quality of life is assessed at baseline, monthly during therapy, every 2 months for 6
months, every 4 months for 1 year, and then every 6 months thereafter.
Patients are followed every 2 months for 6 months, every 4 months for 1 year, and then every
6 months thereafter.
PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Gerard Ganem, MD
Centre Jean Bernard
United States: Federal Government