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Phase III Randomized Trial of Radiosensitization with HU vs HU/5-FU/CDDP vs CDDP in Patients with Stage IIB/III/IVA Cervical Cancer with Negative Para-Aortic Nodes
Basic Trial Information
Objectives I. Determine which of the following treatments is superior in potentiating radiotherapy for locally advanced cervical carcinoma: hydroxyurea (HU); HU/fluorouracil with bolus cisplatin (CDDP); or weekly CDDP. II. Determine the relative toxicities of these treatments when given concurrently with radiotherapy. Entry Criteria Disease Characteristics: Histologically confirmed primary invasive carcinoma of the uterine cervix of one of the following histologies: Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Previously untreated Stage IIB/IIIA/IIIB/IVA disease with negative para-aortic nodes Extraperitoneal para-aortic lymphadenectomy required Pelvic lymphadenectomy not required No known intraperitoneal disease Radiotherapy must begin within 6 weeks of surgery Prior/Concurrent Therapy: Biologic therapy: No prior biologic therapy Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior pelvic irradiation Surgery: Para-aortic lymphadenectomy required Patient Characteristics: Age: Any age Performance status: GOG 0-3 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 x normal SGOT no greater than 3 x normal Renal: Creatinine no greater than 2.0 mg/dl Other: No septicemia or severe infection No other condition that would interfere with completion of the study No past or current second malignancy except nonmelanomatous skin cancer No pregnant women Expected Enrollment 90 patients/year will be entered over approximately 5.5 years. Outline Randomized study. Arm I: Radiotherapy with Single-Agent Radiosensitization. External-beam irradiation with photon energies of at least 4 MeV plus intracavitary irradiation using radium, cesium, or cobalt sources; with Cisplatin, CDDP, NSC-119875. Arm II: Radiotherapy with 3-Drug Radiosensitization. External-beam plus intracavitary irradiation as in Arm I; with Fluorouracil, 5-FU, NSC-19893; CDDP; Hydroxyurea, HU, NSC-32065. Arm III: Radiotherapy with Single-Agent Radiosensitization. External-beam plus intracavitary irradiation as in Arm I; with HU.Published Results Rose PG, Ali S, Watkins E, et al.: Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (19): 2804-10, 2007.[PUBMED Abstract] Rose PG, Bundy BN, Watkins EB, et al.: Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med 340 (15): 1144-53, 1999.[PUBMED Abstract] Related PublicationsGold MA, Tian C, Whitney CW, et al.: Surgical versus radiographic determination of para-aortic lymph node metastases before chemoradiation for locally advanced cervical carcinoma: a Gynecologic Oncology Group Study. Cancer 112 (9): 1954-63, 2008.[PUBMED Abstract] Monk BJ, Tian C, Rose PG, et al.: Which clinical/pathologic factors matter in the era of chemoradiation as treatment for locally advanced cervical carcinoma? Analysis of two Gynecologic Oncology Group (GOG) trials. Gynecol Oncol 105 (2): 427-33, 2007.[PUBMED Abstract] Gold M, Tian C, Whitney CW, et al.: Surgical versus radiologic exclusion of para-aortic lymph node metastases relative to chemoradiation for loco-regionally advanced cervical carcinoma: a meta-analysis of Gynecologic Oncology Group (GOG) protocols 85, 120 & 165. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-39, 2006. Rose PG: Combined-modality therapy of locally advanced cervical cancer. J Clin Oncol 21 (10 Suppl): 211-7, 2003. Monaghan J: Time to add chemotherapy to radiotherapy for cervical cancer. Lancet 353 (9161): 1288-9, 1999.[PUBMED Abstract] Trial Lead Organizations Gynecologic 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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