Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Hydroxyurea; Paclitaxel

Criteria

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