Phase III Randomized Comparison of Radiotherapy with vs without Continuous-Infusion 5-FU/Bolus CDDP Following Radical Hysterectomy and Node Dissection in High-Risk Patients with Stages IA2, IB, and IIA Carcinoma of the Cervix
Basic Trial Information
|Phase III||Treatment||Closed||any age||NCI||SWOG-8797|
GOG-109, RTOG-9112, INT-0107
I. Compare survival, progression-free survival, and failure rate outside the pelvis of patients with Stages IA2, IB, or IIA carcinoma of the cervix with risk factors (positive pelvic nodes, parametrial involvement, or positive surgical margins) randomly assigned following radical hysterectomy to radiotherapy with vs. without fluorouracil/cisplatin. II. Compare the toxicities associated with these 2 regimens.
Primary, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix Clinical Stage IA2/IB/IIA disease required Prior radical hysterectomy with total pelvic lymphadenectomy with, at surgical evaluation, at least 1 of the following: Positive pelvic lymph nodes Parametrial involvement Positive surgical margins Pathologically confirmed para-aortic lymph nodes required Para-aortic nodes not separately sampled allowed if common iliac nodes negative Positive common iliac nodes allowed if para-aortic nodes negative No unresectable nodal disease
Biologic therapy: No prior immunotherapy (including biologics) Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal cancer therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: Radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling required within 6 weeks of registration
Age: Any age Performance status: SWOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin within ULN Renal: No "horseshoe kidney" detected by CT, sonogram, or IVP Creatinine within ULN Other: Capable of beginning therapy within 5 working days of registration No history of severe pelvic inflammatory disease defined as 1 or more of the following: Requiring surgical drainage Requiring hysterectomy/salpingo-oophorectomy Inducing sterility Producing symptomatic sequelae No sepsis or grade 3 or worse infection No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Curatively-treated Stage I cervical carcinoma Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams other than blood/body fluid analyses and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration
240 patients will be randomized over 5.5 years.
Randomized study. Arm I: Radiotherapy plus 2-Drug Combination Chemotherapy. Pelvic irradiation with x-ray beams of at least 4 MV; plus Fluorouracil, 5-FU, NSC-19893; Cisplatin, CDDP, NSC-119875. Arm II: Radiotherapy. Pelvic irradiation as in Arm I.
Liao SY, Darcy KM, Randall LM, et al.: Prognostic relevance of carbonic anhydrase-IX in high-risk, early-stage cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 116 (3): 452-8, 2010.[PUBMED Abstract]
Randall LM, Monk BJ, Darcy KM, et al.: Markers of angiogenesis in high-risk, early-stage cervical cancer: A Gynecologic Oncology Group study. Gynecol Oncol 112 (3): 583-9, 2009.[PUBMED Abstract]
Monk BJ, Wang J, Im S, et al.: Rethinking the use of radiation and chemotherapy after radical hysterectomy: a clinical-pathologic analysis of a Gynecologic Oncology Group/Southwest Oncology Group/Radiation Therapy Oncology Group trial. Gynecol Oncol 96 (3): 721-8, 2005.[PUBMED Abstract]
Im SS, Monk BJ, Wang J, et al.: Rethinking the use of chemotherapy and radiation after radical hysterectomy: a clinical-pathologic analysis of SWOG 8797/GOG 109. [Abstract] Gynecol Oncol 92: A-8, 396, 2004.
Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al.: Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 18 (8): 1606-13, 2000.[PUBMED Abstract]
Peters WA, Liu PY, Barrett R, et al.: Cisplatin, 5-fluorouracil plus radiation therapy are superior to radiation therapy as adjunctive therapy in high-risk, early stage carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: report of a phase III intergroup study. [Abstract] Proceedings of the Society of Gynecologic Oncologists A1, 1999.
Gold M, Smith C, Hyde J Jr, et al.: High risk early stage cervical cancer following radical hysterectomy: chemoradiation with weekly cisplatin or cisplatin/5-FU per GOG 109? [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-68, 2006.
Monaghan J: Time to add chemotherapy to radiotherapy for cervical cancer. Lancet 353 (9161): 1288-9, 1999.[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]
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
Gynecologic Oncology Group
Radiation Therapy Oncology Group
Ph: 314-362-8502; 800-600-3606
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.