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Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix Clinical research trials and Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix clinical trial. Human subjects often get the best healthcare possible for their Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix  Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
For Condition: stage 3 cervical cancer,cervical squamous cell carcinoma,cervical adenocarcinoma,cervical adenosquamous cell carcinoma,radiation toxicity,stage 4A cervical cancer
Status: Suspended
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as cisplatin, 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. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.
Details: OBJECTIVES: - Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix. - Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients. - Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients. OUTLINE: - Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters. - Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 66 patients (27 for phase I and 39 for phase II) will be accrued for this study within 12-30 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven, locally advanced carcinoma of the uterine cervix - TNM classification stage IIIB or IVA - Disease metastatic to para-aortic or high common iliac lymph nodes - Prior complete surgical resection of involved lymph nodes or gross residual tumor involvement of a lymph node allowed - The following cellular types are eligible: - Squamous cell carcinoma - Adenocarcinoma - Adenosquamous carcinoma - The following cellular types are ineligible: - Small cell carcinoma - Carcinoid tumor - Glassy cell carcinoma - Clear cell carcinoma - Cystadenocarcinoma - No metastatic disease outside of the pelvis (except to the para-aortic nodes) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - At least 6 months Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT no greater than 2 times normal Renal - Creatinine no greater than 1.5 mg/dL (urinary diversion allowed) - Corrected calcium normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant concurrent medical condition that would preclude study participation - No insulin-dependent diabetes - No prior or concurrent malignancy within the past 3 years except cutaneous basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior pelvic irradiation except transvaginal radiotherapy to control bleeding Surgery - See Disease Characteristics - No prior tumor-directed surgery except lymph node biopsy/staging
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamSmall, Study Chair, Robert H. Lurie Cancer Center
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
United States
Dixie Regional Medical Center
St. George, Utah, 84770
United States
Baptist Hospital of Miami
Miami, Florida, 33256-2110
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
United States
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, 27533
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
St. Mary's Hospital
Milwaukee, Wisconsin, 53201
United States
Akron City Hospital
Akron, Ohio, 44304
United States
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
Mills-Peninsula Health Services
Burlingame, California, 94010
United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0293
United States
Additional Information:
Study ID Numbers: CDR0000068472; RTOG-C-0116
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012012
Other Cervical Adenocarcinoma Studies:
1. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
2. Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
3. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
4. Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
5. Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Related Studies:
Other cervical adenocarcinoma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
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