NCT00047112

Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 74 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Detailed description

OBJECTIVES: * Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone. * Compare the disease-free survival of patients treated with these regimens. * Compare the surgical mortality and morbidity of patients treated with these regimens. * Compare the resectability of patients treated with these regimens. * Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection. * Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 2002-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2003-01-27
• Last updated: 2020-03-30

Locations

73 sites across 4 countries: Belgium, France, Germany, Netherlands