Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can 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 II esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction No T1-2, N0, M0 disease No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction + Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction No evidence of distant metastases Tumor must be considered surgically resectable - Patients with T4, N0 tumors that are potentially resectable are eligible No clinically relevant pleural or peritoneal effusion that is not amenable to drainage PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 12 weeks Absolute neutrophil count ≥1,500/mm^3 Platelet count ≥100,000/mm^3 Hemoglobin ≥10 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 3 times ULN Creatinine clearance ≥ 45 mL/min No New York Heart Association class III or IV congestive heart failure Pregnant or nursing women are ineligible Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No other severe underlying disease that would preclude study entry No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin Able to swallow pills PRIOR CONCURRENT THERAPY: No prior chemotherapy for esophageal cancer No prior radiotherapy field that overlapped the anticipated fields of study radiotherapy No prior radiotherapy to > 30% of the marrow cavity Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to discontinue use 2 days prior, during, and 2 days after pemetrexed disodium administration (5 days prior for long-life NSAIDs) Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and while receiving protocol therapy
Sites / Locations
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- Graham Hospital
- Memorial Hospital
- St. Anthony's Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Hospital
- Sparrow Regional Cancer Center
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- Albert Lea Cancer Center at Albert Lea Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- St. Francis Cancer Center at St. Francis Medical Center
- HealthEast Cancer Care at St. Joseph's Hospital
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- David L. Rike Cancer Center at Miami Valley Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
Arms of the Study
Arm 1
Experimental
Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation