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Phase III Pelvic vs Pelvic plus Para-Aortic Radiotherapy in Stage IIB or Bulky IB/IIA Cervical Carcinoma
Basic Trial Information
Objectives I. Determine the value of pelvic radiation vs. pelvic and para-aortic node irradiation when para-aortic nodes are clinically negative in Stage IIB, bulky Stage IB and IIA cervical carcinoma as measured by relapse-free survival and total survival. II. Determine the increased morbidity, if any, of extended para-aortic irradiation as against pelvic irradiation only in terms of early and late complications. III. Determine the superiority, if any, of various treatment techniques employed in para-aortic irradiation. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically proven FIGO Stage IIB or bulky Stage IB/IIA cervical carcinoma (without clinical evidence of para-aortic nodal involvement, April 1980 Revision) who have not undergone curative surgery or prior radiotherapy to the target site. Patients must be between 18 and 75 years old with a Karnofsky performance status of 40 or better. Patients must have adequate bone marrow and renal status. Expected Enrollment 364 patients will be entered in 6 years. Outline Randomized study. Arm I: Radiotherapy. Pelvic irradiation using supervoltage equipment (Co-60 or higher energy). Arm II: Radiotherapy. Irradiation of the pelvis and para-aortic region.Published Results Rotman M, Pajak TF, Choi K, et al.: Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA 274 (5): 387-93, 1995.[PUBMED Abstract] Rotman M, Choi K, Guse C, et al.: Prophylactic irradiation of the para-aortic lymph node chain in stage IIB and bulky stage IB carcinoma of the cervix, initial treatment results of RTOG 7920. Int J Radiat Oncol Biol Phys 19 (3): 513-21, 1990.[PUBMED Abstract] Trial Lead Organizations Radiation Therapy Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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