Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable|
- overal survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- recurrence free survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
|Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy|
Active Comparator: CHIRURGIE SEULE
|Procedure: conventional surgery|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047112
Show 73 Study Locations
|Study Chair:||J. P. Triboulet||Centre Hospitalier Regional et Universitaire de Lille|
|Study Chair:||Jean-Francois Seitz, MD||Institut Paoli-Calmettes|