Phase III Randomized Study of Radiotherapy with vs without Weekly CDDP Followed by Adjuvant Hysterectomy in Patients with Bulky Stage IB Carcinoma of the Cervix
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-123|
I. Determine whether weekly cisplatin improves locoregional control and survival when added to a regimen of radiotherapy and adjuvant extrafascial hysterectomy in patients with bulky Stage IB carcinoma of the cervix. II. Determine the relative toxicities of radiotherapy plus cisplatin vs. radiotherapy alone in these patients.
Histologically confirmed, previously untreated, Stage IB carcinoma of the cervix of one of the following histologies: Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Bulky disease required, i.e., at least 4 cm or barrel shaped Pelvic and para-aortic lymph nodes must be radiographically or surgically negative Positive or suspicious lesions on CT scan or lymphangiogram require negative fine-needle aspiration cytology or histologic confirmation of negative nodes Entry within 8 weeks of diagnosis required
Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior partial or total hysterectomy
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: Able to undergo surgery and complete therapy and follow-up No prior or concomitant second malignancy except nonmelanomatous skin cancer
317 patients will be entered at an estimated accrual rate of 55 patients/year.
Randomized study. Arm I: Radiotherapy followed by Surgery. External beam irradiation using x-rays with a minimum energy of 4 MeV plus intracavitary irradiation using Cesium, Ce; followed by extrafascial hysterectomy. Arm II: Radiotherapy plus Radiosensitization/Chemotherapy followed by Surgery. External beam plus intracavitary irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875; followed by extrafascial hysterectomy.
Stehman FB, Ali S, Keys HM, et al.: Radiation therapy with or without weekly cisplatin for bulky stage 1B cervical carcinoma: follow-up of a Gynecologic Oncology Group trial. Am J Obstet Gynecol 197 (5): 503.e1-6, 2007.[PUBMED Abstract]
Keys HM, Bundy BN, Stehman FB, et al.: Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med 340 (15): 1154-61, 1999.[PUBMED Abstract]
Kunos C, Ali S, Abdul-Karim FW, et al.: Posttherapy residual disease associates with long-term survival after chemoradiation for bulky stage 1B cervical carcinoma: a Gynecologic Oncology Group study. Am J Obstet Gynecol 203 (4): 351.e1-8, 2010.[PUBMED Abstract]
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
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.