Phase III Comparison of Pelvic Irradiation with Concurrent CDDP/5-FU vs Pelvic and Para-Aortic Irradiation without Chemotherapy in Patients with High-Risk Carcinoma of the Cervix
Basic Trial Information
|Phase III||Treatment||Closed||any age||NCI||RTOG-9001|
I. Compare response rates and survival of patients with high-risk carcinoma of the cervix (Stages IIB-IVA and Stages IB and IIA with proven pelvic node involvement or tumors of 5 cm or greater) randomly assigned to standard-field pelvic irradiation plus concomitant fluorouracil/cisplatin vs. extended-field irradiation (pelvic plus para-aortic fields) without chemotherapy. II. Compare the toxicities of these 2 therapeutic regimens.
Histologically proven FIGO Stages IIB through IVA carcinoma of the cervix Stages IB and IIA disease included provided there is biopsy-proven pelvic node involvement or tumor size of 5 cm or greater Acceptable histologies include: Squamous cell Adenocarcinoma Adenosquamous carcinoma Excluded histologies: Small cell, carcinoid, glassy cell, clear cell, and adenoid cystic No para-aortic lymph node involvement as determined by bipedal lymphangiography or surgical exploration Biopsy confirmation, preferably by fine needle aspiration, required for suspicious or positive lymphangiogram Lymphangiogram strongly recommended prior to staging surgery
Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No pelvic irradiation other than trans-vaginal to control bleeding Surgery: No surgery other than exploratory laparotomy or biopsy
Age: Any age Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hb at least 10 g/dl Hepatic: Bilirubin no greater than 1.5 mg/dl Renal: Creatinine no greater than 1.5 mg/dl BUN no greater than 25 mg/dl (urinary diversion allowed to improve renal function) Other: No insulin-dependent diabetes No HIV infection (HIV testing not required) No general medical problems to preclude full-dose chemotherapy No second malignancy except basal cell skin cancer
400 patients will be entered over 3-4 years.
Randomized study. Arm I: Radiotherapy plus Radiosensitization with 2-Drug Combination Chemotherapy. External-beam whole-pelvic irradiation using beams with energies of at least 4 MeV and intracavitary implants with radium or cesium; plus Fluorouracil, 5-FU, NSC-19893; Cisplatin, CDDP, NSC-119875. Arm II: Radiotherapy. External-beam whole-pelvic and para-aortic irradiation and intracavitary implants with equipment as in Arm I.
Eifel PJ, Winter K, Morris M, et al.: Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol 22 (5): 872-80, 2004.[PUBMED Abstract]
Eifel PJ, Winter K, Morris M, et al.: Pelvic radiation with concurrent chemotherapy versus pelvic and para-aortic radiation for high-risk cervical cancer: an update of RTOG 90–01. [Abstract] Int J Radiat Oncol Biol Phys 54 (2 suppl 1): 1, 2002.
Morris M, Eifel PJ, Lu J, et al.: Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 340 (15): 1137-43, 1999.[PUBMED Abstract]
Torres MA, Jhingran A, Thames HD Jr, et al.: Comparison of treatment tolerance and outcomes in patients with cervical cancer treated with concurrent chemoradiotherapy in a prospective randomized trial or with standard treatment. Int J Radiat Oncol Biol Phys 70 (1): 118-25, 2008.[PUBMED Abstract]
Wolfson AH, Winter K, Crook W, et al.: Are increased tumor aneuploidy and heightened cell proliferation along with heterogeneity associated with patient outcome for carcinomas of the uterine cervix? A combined analysis of subjects treated in RTOG 9001 and a single-institution trial. Int J Radiat Oncol Biol Phys 70 (1): 111-7, 2008.[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
Radiation Therapy Oncology Group
Ph: 713-745-3000; 800-392-1611
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.