Esophageal Cancer Clinical Trial
Official title:
A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. It is not yet known whether surgery is more effective with or without chemotherapy
and radiation therapy for cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without
combination chemotherapy and radiation therapy in treating patients who have cancer of the
esophagus that can be surgically removed.
Status | Completed |
Enrollment | 56 |
Est. completion date | March 2000 |
Est. primary completion date | March 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
1. Patients with histologically documented untreated squamous cell carcinoma or
adenocarcinoma of the thoracic esophagus (below 20 cm) or gastro-esophageal junction
and with less than 2 cm distal spread into the gastric cardia were eligible. 2. No evidence of distant metastatic disease by history and physical examination 3. Upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies are required. 4. Bone scan is required for alkaline phosphatase more than 3X the institutional normal value. 5. Bronchoscopy is required if the primary tumor was adjacent to the trachea or left main stem bronchus. 6. Patients are required to have: - granulocyte counts =1,800/mL - platelet count = 100,000/mL - creatinine clearance = 50 mL/min 7. Esophageal ultrasound (EUS) and preresection staging by thoracoscopy (ts) and laparoscopy/minilaparotomy (ls), including biopsy of celiac axis and lesser curvature are recommended 8. Tumors must be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases. 9. Patients with supraclavicular lymph nodes measuring = 1.5 cm by CT (not palpable) are eligible. 10. Patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) =1.5 cm by CT. 11. Patients may not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. 12. Patients with previous malignancies are eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. 13. There can be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. Patients with uncontrolled or severe cardio- vascular disease,pulmonary disease, oractive infections are excluded. 14. Pregnant patients are excluded. 15. Informed consent is required for all patients. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois at Chicago Health Sciences Center | Chicago | Illinois |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | North Shore University Hospital | Manhasset | New York |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | Mount Holly | New Jersey |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center, NY | New York | New York |
United States | New York Presbyterian Hospital - Cornell Campus | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Krasna M, Tepper JE, Niedzwiecki D, et al.: Trimodality therapy is superior to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Fra
Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: — View Citation
Tepper JE, Krasna M, Niedzwiecki D, et al.: Superiority of trimodality therapy to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] J Clin Oncol 24 (Suppl 18): A-4012, 2006.
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