Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage III esophageal cancer, stage IV esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer, including the gastroesophageal junction Squamous cell or adenocarcinoma Unresectable disease Meets 1 of the following staging criteria by endoscopic ultrasound: Cervical (supraclavicular) lesion, meeting 1 of the following stages: TX, N+ disease T3-4, NX disease TX, NX, M1a* disease Thoracic (celiac) lesion, meeting 1 of the following stages: Unresectable T4, NX disease TX, NX, M1a* disease Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography No T1-2, N0 disease All tumors encompassable in 1 radiation field No tumor with esophagotracheal fistula PATIENT CHARACTERISTICS: Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST ≤ 1.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine clearance > 60 mL/min Cardiovascular No myocardial infarction within the past 3 months No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No significant arrhythmias No other severe cardiovascular disease Immunologic No uncontrolled active infection No active autoimmune disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment No definite contraindication to corticosteroids No uncontrolled diabetes mellitus No pre-existing peripheral neuropathy > grade 1 No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent No other serious underlying medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy to the chest Other More than 30 days since prior experimental treatment in another clinical trial No other concurrent experimental drugs
Sites / Locations
- Hirslanden Klinik Aarau
- Saint Claraspital AG
- Universitaetsspital-Basel
- Inselspital Bern
- Kantonsspital Bruderholz
- Kantonsspital Graubuenden
- Kantonsspital
- Kantonsspital - St. Gallen
- Regionalspital
- City Hospital Triemli
Arms of the Study
Arm 1
Active Comparator
Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.