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Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer Clinical research trials and Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer. Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer  Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
For Condition: stage 1B cervical cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase III trial to compare surgery with or without chemotherapy in treating patients who have stage IB cervical cancer.
Details: OBJECTIVES: I. Compare disease free survival, overall survival, and local control in patients with bulky stage IB carcinoma of the cervix treated with radical hysterectomy and pelvic and para-aortic lymphadenectomy with or without neoadjuvant vincristine and cisplatin. II. Compare adverse effects of radical hysterectomy and pelvic and para-aortic lymphadenectomy with or without neoadjuvant vincristine and cisplatin in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Surgery. All patients undergo intra-abdominal and retroperitoneal exploratory laparotomy. Patients without metastases also undergo radical hysterectomy with pelvic and para-aortic lymphadenectomy. Beginning 2-4 weeks after surgery, patients with 1 or more positive lymph nodes or positive surgical margins on the radical hysterectomy specimen receive adjunctive radiotherapy 5 days each week for 4-6 weeks. Patients with histologically confirmed metastases do not undergo radical hysterectomy with pelvic and para-aortic lymphadenectomy, but receive radiotherapy 5 days each week for 6-8 weeks beginning 2-4 weeks after the laparotomy. Patients who undergo radiotherapy also receive cisplatin IV over 1 hour on days when radiotherapy is administered for up to 6 doses of cisplatin. Arm II: Patients receive vincristine IV bolus immediately followed by cisplatin IV over 1 hour on days 1, 11, and 21. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning approximately 4 weeks after the last doses of neoadjuvant vincristine and cisplatin, patients receive surgery, radiotherapy, and cisplatin as in Arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 170-340 patients will be accrued for this study over approximately 4.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Previously untreated, histologically proven invasive carcinoma of the cervix - Eligible histologies: Squamous; Adenocarcinoma; Adenosquamous - Eligible stages: Bulky stage IB, i.e.: Exophytic lesions 4 cm or greater in diameter OR Cervix expanded to 4 cm or greater and presumed clinically to result from cancer; No extension beyond cervix clinically and by IVP or CT with contrast --Prior/Concurrent Therapy-- - No prior therapy for cervical cancer - No prior pelvic irradiation --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; AST no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal - Renal: Creatinine no greater than 2.0 mg/dL - Other: No septicemia or severe infection; No other concurrent malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer and prior malignancy therapy does not contraindicate current protocol therapy Suitability for radical hysterectomy and lymphadenectomy required
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryEddy, Study Chair, Gynecologic Oncology Group
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Southern California Permanante Medical Group
Bellflower, California, 90706
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Fletcher Allen Health Care
Burlington, Vermont, 05401
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000078470; GOG-141
Study Start Date: December 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002536
Other Stage 1b Cervical Cancer Studies:
1. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
2. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
3. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
4. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
5. Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
Related Studies:
Other stage 1B cervical cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer
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