FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the esophagus stage III (according to UICC classification)

• Measurable disease according to the RECIST criteria

• WHO performance status of 0 or 1

• Age 18-80 years old

• Reference imaging within the 2 weeks prior to the treatment

• Hematological and biochemical assessment within the 2 weeks prior to the treatment

• Neutrophils >1.5 10 9/L, platelets >150.10 9/L, Haemoglobin ≥10g/dL, Bilirubin ≤ 1.25 ULN, Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 ULN Woman of childbearing potential must use effective contraception methods Written informed consent obtained No prior chemotherapy or radiation therapy for esophageal cancer

Exclusion Criteria:

• Stage I, II or IV (according to UICC classification)

• Esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor

• visceral metastasis

• orotracheal fistula weight loss >15% within the previous 6 months Pregnancy or breast feeding Contra indication to the study treatment History of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months

• Peripheral Neuropathy NCI >1

• Liver Failure

• Prior thoracic radiation therapy

• history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus Esophageal Endoprosthesis