NCT00578201

FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and spread Cetuximab may also make tumor cells more sensitive to radiation therapy. Drug used in chemotherapy such as oxaliplatin leucovorin and Fluorouracil work in different way to stop the growth of tumor cells either by killing the cells or by stopping them form dividing. Radiation therapy uses high energy X rays to kill tumor cells. Giving cetuximab could improve the efficacy of chemotherapy and radiation therapy and may make the tumor smaller 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.

Conditions

• Esophageal Cancer Stage III

Interventions

Type	Name	Description
DRUG	radiochemotherapy,combination Cetuximab-FOLFOX	objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-12-21
• Last updated: 2011-03-31

Locations

1 site across 1 country: France