Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
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 II esophageal cancer, stage III esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction Primary (non-recurrent) disease Amenable to resection Stage greater than T1, N0 by endoscopic ultrasound Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue Tumor may not extend more than 2 cm into the stomach No multiple primary carcinomas of the esophagus No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus No evidence of disseminated cancer Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies Palpable supraclavicular nodes must be negative for cancer by biopsy Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion No celiac adenopathy greater than 2 cm PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to comprehend study requirements and considered likely to comply with study parameters No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix No uncontrolled diabetes No hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 5 years since prior systemic chemotherapy Endocrine therapy Not specified Radiotherapy No prior chest or upper abdomen radiotherapy Surgery No prior esophageal or gastric surgery Other No concurrent photodynamic therapy No other concurrent investigational agents for esophageal carcinoma
Sites / Locations
- Providence Saint Joseph Medical Center - Burbank
- Saint Rose Hospital
- Providence Holy Cross Cancer Center
- CCOP - Bay Area Tumor Institute
- Summit Medical Center
- Valley Care Medical Center
- J.C. Robinson, M.D. Regional Cancer Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Hospital of Saint Raphael
- Baptist-South Miami Regional Cancer Program
- Gulf Coast Cancer Treatment Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Mount Sinai Hospital Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Wendt Regional Cancer Center at Finley Hospital
- Ochsner Clinic of Baton Rouge
- CCOP - Ochsner
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Green Bay Oncology, Limited - Iron Mountain
- Foote Hospital
- Sparrow Regional Cancer Center
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- Hattiesburg Clinic, P.A.
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Siteman Cancer Center at Barnes-Jewish Hospital
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Monmouth Medical Center
- Fox Chase Virtua Health Cancer Program - Marlton
- Booker Cancer Center at Riverview Medical Center
- Community Regional Cancer Center at Community Medical Center
- Albuquerque Regional Medical Center at Lovelace Sandia Health System
- University of New Mexico Cancer Research and Treatment Center
- SUNY Downstate Medical Center
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilmed Radiation Oncology Services
- Akron City Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cancer Treatment Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Bryn Mawr Hospital
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- M.D. Anderson Cancer Center at University of Texas
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- LDS Hospital
- Schiffler Cancer Center at Wheeling Hospital
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
Arms of the Study
Arm 1
Experimental
ChemoRT and selective surgery
Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.