Trial Information

Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens

OBJECTIVES:

- Compare the survival and failure patterns in patients with previously untreated
carcinoma of the esophagus or gastroesophageal junction treated with cisplatin,
paclitaxel, and concurrent radiotherapy with or without fluorouracil.

- Compare the tolerance of these regimens by these patients.

- Compare the overall quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma
vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients
are randomized to one of two treatment arms.

- Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously
over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over
24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment
repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease
after the first course of induction therapy receive a second course of therapy.
Patients with local disease progression after the first course proceed to
chemoradiotherapy.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo
radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously
over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on
days 1, 8, 15, 22, and 29.

- Arm II: Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel
IV over 3 hours on day 1. Treatment continues every 3 weeks for 2 courses as in arm I.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo
radiotherapy as in arm I. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and
36, and paclitaxel IV continuously over 96 hours on days 1-4, 8-11, 15-18, 22-25, 29-32, and
36-39.

Quality of life is assessed at baseline, within 1 week after radiotherapy, at 6 weeks after
study completion, every 4 months for 1 year, every 6 months for 2 years, and then annually
for 5 years.

Patients are followed within 8 weeks, every 4 months for 1 year, every 6 months for two
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this
study within 21 months.