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Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva Clinical research trials and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva  Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
For Condition: stage 2 vulvar cancer,stage 1 vulvar cancer,stage 3 vulvar cancer,squamous cell carcinoma of the vulva
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.
Details: OBJECTIVES: I. Compare the recurrence-free interval and survival in patients with stage I, II, or III squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin. II. Compare the toxicity of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage I, II, or III (at clinical presentation) squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both: At least 1 positive inguinal and/or femoral lymph node; No inoperable (fixed or ulcerating) groin nodes; Must not require resection of urethra or anal sphincter to achieve negative margins - Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization - No metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy - Surgery: See Disease Characteristics; No more than 8 weeks since prior surgery --Patient Characteristics-- - Age: Any age - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal - Renal: Creatinine no greater than 2.0 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GillianThomas, Study Chair, Gynecologic Oncology Group
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
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
M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Mallinckrodt Institute of Radiology
St. Louis, Missouri, 63108
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
Additional Information:
Study ID Numbers: CDR0000068103; GOG-0185
Study Start Date: March 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006096
Other Stage 1 Vulvar Cancer Studies:
1. Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
2. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
3. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
Related Studies:
Other stage 1 vulvar cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
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