|
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical research trials and Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus clinical trial. Subjects typically recieve the finest healthcare available for their Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus  Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
For Condition: stage 3 esophageal cancer,stage 2 esophageal cancer,stage 1 esophageal cancer,squamous cell carcinoma of the esophagus,Adenocarcinoma of the Esophagus
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group,Radiation Therapy Oncology Group,Eastern Cooperative Oncology Group,Cancer and Leukemia Group B
Synopsis: 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.
Details: OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant radiotherapy followed by surgical resection versus patients receiving surgery alone. II. Assess and compare the toxicities of each approach. III. Compare the incidence and pattern of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence. V. Evaluate the ability of preresection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI. Evaluate the impact of lymph nodes on survival and recurrence. PROTOCOL OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer (squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If there is no disease progression or unresectable disease, surgery is performed within 3-8 weeks following completion of therapy. Patients in arm II undergo surgery alone no later than 6 weeks postrandomization. Patients are followed at least every 3 months for two years, then every 6 months for the next two years, and annually thereafter. PROJECTED ACCRUAL: There will be 500 patients accrued into this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus or gastroesophageal junction; Stages I, IIA, IIB, or III - Tumor must be considered surgically resectable - No positive supraclavicular nodes (greater than 1.5 cm by CT) or palpable supraclavicular nodes - No positive (greater than 1.5 cm by CT) nodes in levels 15-20 - Lymph node involvement in levels 15, 16, and 20 that are no greater than 1.5 cm by CT allowed; Patient without radiographical evidence of lymph node involvement in levels 15, 16, and 20 that are proven positive at time of presurgical staging also allowed - Radiographically positive lymph node involvement in levels 17-19 allowed only if proven to be negative by biopsy; No positive lymph node involvement in levels 17-19 even if there was no radiographic evidence of lymph node involvement - No tumors with greater than 2 cm distal spread into the gastric cardia - No distant metastases (suspicious lesions on CT should be tested by ultrasound, MRI or biopsy) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for this malignancy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy that would overlap the field(s) treated in this study - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,800/mm3; Platelet count at least 100,000/mm3 - Hepatic: If alkaline phosphatase is greater than 3 times normal, must undergo esophagoscopy with biopsy, barium esophagogram, CT scan of the chest and upper abdomen, and bone scan - Renal: Creatinine clearance at least 50 mL/min - Other: No other prior malignancy unless disease free for greater than 5 years
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkKrasna, Study Chair, Cancer and Leukemia Group B
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Additional Information:
Study ID Numbers: CDR0000065873; CLB-C9781,E-C9781,NCCTG-C9781,RTOG-9716
Study Start Date: October 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003118
Other Adenocarcinoma Of The Esophagus Studies:
1. Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
2. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
3. Positron Emission Tomography in Determining Stage of Esophageal Cancer
4. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Related Studies:
Other Adenocarcinoma of the Esophagus Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
|
|
|
|
|
|
|
|
