|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
Last Modified: 4/8/2011
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.
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
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
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
90 patients/year will be entered over approximately 5.5 years.
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 Publications
Rose PG, Ali S, Whitney CW, et al.: Outcome of stage IVA cervical cancer patients with disease limited to the pelvis in the era of chemoradiation: a Gynecologic Oncology Group study. Gynecol Oncol 121 (3): 542-5, 2011.[PUBMED Abstract]
Rose PG, Ali S, Whitney CW, et al.: Impact of hydronephrosis on outcome of stage IIIB cervical cancer patients with disease limited to the pelvis, treated with radiation and concurrent chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol 117 (2): 270-5, 2010.[PUBMED Abstract]
Kunos C, Tian C, Waggoner S, et al.: Retrospective analysis of concomitant Cisplatin during radiation in patients aged 55 years or older for treatment of advanced cervical cancer: a gynecologic oncology group study. Int J Gynecol Cancer 19 (7): 1258-63, 2009.[PUBMED Abstract]
Gold 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.
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.