Title
Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
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
Phase
Phase 1/Phase 2Study Type
InterventionalStatus
Unknown statusIndication/Condition
Esophageal CancerIntervention/Treatment
fluorouracil paclitaxel hydroxyurea ...Study Participants
NoneRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.
OBJECTIVES:
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 treatment arms.
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 unacceptable toxicity.
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 of chemoradiotherapy.
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.
DISEASE CHARACTERISTICS: Histologically confirmed stage II (T2 or T3, N0, M0) or III (T3, N1, M0) epidermoid carcinoma of the esophagus Inoperable due to initial extension or inoperable with no extension No visceral metastases No extension to the tracheo-bronchial pathway No tracheo-esophageal fistula No broncho-esophageal fistula No suspected respiratory mucosal involvement on bronchoscopy No carcinoma in situ PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 120,000/mm^3 Hemoglobin at least 10 g/dL Neutrophil count at least 1,500/mm^3 Lymphocyte count at least 1,000/mm^3 Hepatic: SGOT and SGPT no greater than 2 times normal Albumin at least 3.0 g/dL Renal: Creatinine no greater than 1.4 mg/dL Calcium less than 11.2 mg/dL Pulmonary: See Disease Characteristics No severe respiratory illness (e.g., severe broncho-pathway obstruction or insufficient respiration) No uncontrolled broncho-pulmonary infection Other: No other prior history of malignancy except curatively treated carcinoma in situ of the colon or skin cancer No contraindication to fluorouracil Not pregnant or nursing Fertile patients must use effective contraception No psychiatric illness HIV negative Total protein at least 65% of normal PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No concurrent participation in other study
