Phase III Randomized Comparison of 5-FU/CACP vs HU As Potentiators of Radiotherapy in Patients with Stages IIB, III, and IVA Carcinoma of the Cervix with Negative Para-Aortic Nodes
Basic Trial Information
|Phase III||Treatment||Closed||any age||NCI||GOG-85|
I. Determine whether hydroxyurea or the combination of 5-fluorouracil/cis-platinum is superior as a potentiator of radiotherapy in patients with Stages IIB, III, and IVA carcinoma of the cervix with negative para-aortic nodes. II. Compare response rates, time to progression, survival, and patterns of recurrence in these two patient groups. III. Compare the toxicities of these two chemotherapeutic regimens when administered concomitantly with radiotherapy.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients of any age with previously untreated, histologically confirmed invasive carcinoma of the cervix (squamous, adeno, or adenosquamous), Stages IIB, IIIA, IIIB, and IVA, provided they have had para-aortic lymphadenectomy and intraperitoneal exploration. The para-aortic nodes and cytologic washings must be negative for tumor, and there must be no evidence of intraperitoneal disease. Pelvic lymphadenectomy is not a requirement for this protocol. The WBC must be at least 3,000, platelets at least 100,000, creatinine not over 2.0 mg/dl, and alkaline phosphatase, bilirubin, and SGOT not over twice normal. The GOG performance grade must be 3 or better. There shall have been no previous or concomitant second malignancy aside from nonmelanomatous skin cancer, and patients must not have had prior cytotoxic chemotherapy or pelvic irradiation. Septicemia and severe infection exclude.
About 340 patients will be entered over about 3.5 years.
Randomized study. Patients with Stage IIB disease receive Radiotherapy on Regimen A, while those with Stage III or IVA disease enter Regimen B. All patients are randomized for concomitant Chemotherapy on Arms I and II. Regimen A: Radiotherapy. External beam irradiation of all involved sites and associated nodal regions using x-rays of 4 MeV or greater or Co60, followed by intracavitary implantation (brachytherapy) using radium, cobalt, or cesium sources. Total external beam dose is 4,080 cGy. Regimen B: Radiotherapy. Irradiation of the same volume with the same modalities as in Regimen A. Total external beam dose is 5,100 cGy. Arm I: 2-Drug Combination Chemotherapy. 5-Fluorouracil, 5-FU, NSC-19893; cis-Platinum, CACP, NSC-119875. Arm II: Single-Agent Chemotherapy. Hydroxyurea, HU, NSC-32065.
Whitney CW, Sause W, Bundy BN, et al.: Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol 17 (5): 1339-48, 1999.[PUBMED Abstract]
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]
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]
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 Contact Information
Trial Lead Organizations
Gynecologic Oncology Group
Southwest 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.