Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Procedure: conventional surgeryProcedure: neoadjuvant therapyRadiation: radiation therapy
- Registration Number
- NCT00047112
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE conventional surgery CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE neoadjuvant therapy CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE radiation therapy CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIRURGIE SEULE conventional surgery CHIRURGIE SEULE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE cisplatin CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE fluorouracil CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
- Primary Outcome Measures
Name Time Method overal survival 2010
- Secondary Outcome Measures
Name Time Method recurrence free survival 2010
Trial Locations
- Locations (71)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universiteit Gent
🇧🇪Ghent, Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
🇧🇪Mons, Belgium
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
Centre Paul Papin
🇫🇷Angers, France
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
CHU Ambroise Pare
🇫🇷Boulogne Billancourt, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
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