Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.
- To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil,
and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic
regimen) in patients with inoperable esophageal cancer. (Phase II)
- To assess the endoscopic complete response rate in patients treated with these
regimens. (Phase II)
- To compare the event-free survival of patients treated with these regimens. (Phase III)
- To assess the toxicity profile of these regimens using the NCI CTC v2.0 criteria.
- To compare the overall survival, endoscopic complete response rate, incidence of grade
3-4 toxicities, and time to treatment failure in patients treated with these regimens.
- To evaluate the quality of life of these patients using EORTC QLQ-C30 (version 3) and a
validated disease-specific module EORTC QLQ-OES18. (Phase III)
OUTLINE: This is a multicenter study. Patients are stratified according to histological type
(adenocarcinoma or adenosquamous carcinoma vs squamous cell carcinoma), pretreatment weight
loss within the past 6 months (grade 1 [< 10%] vs grade 2 [≥ 10%]), ECOG performance status
(0 vs 1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (modified FOLFOX 4 regimen): Patients undergo radiotherapy 5 days a week for 5
weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2
hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously
over 46 hours on days 1 and 2. Treatment with chemotherapy repeats every 2 weeks for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (Herskovic regimen): Patients undergo radiotherapy as in arm I. Patients also
receive cisplatin IV continuously over 24 hours on day 1 and fluorouracil IV
continuously over 96 hours on days 1-4 of weeks 1, 5, 8, and 11 in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, periodically during study therapy, and then every 6
months for 1 year and annually for 3 years after completion of study therapy.
After completion of study therapy, patients are followed at 4 weeks and then every 3-6
months until disease progression.
PROJECTED ACCRUAL: A total of 97 patients will be accrued for the phase II portion of the
study. A total of 169 patients will be accrued for the phase III portion of the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients who complete the full study treatment (Phase II)
Thierry Conroy, MD
Centre Alexis Vautrin