Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage IVA cancer of the cervix.

Timeline

Start

1997-10

Primary completion

2005-11

Completion

—

Outcome

Missed primary endpoint

paper The study was closed prematurely when a planned interim futility analysis indicated that PVI FU/RT had a higher treatment failure rate PMID 16230678 ↗

paper In this study, PVI FU does not show improved outcome over weekly cisplatin. PMID 16230678 ↗

Publications

• Background Rose PG, Ali S, Whitney CW, Lanciano R, Stehman FB. 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. 2011 Jun 1;121(3):542-5. doi: 10.1016/j.ygyno.2011.02.024. Epub 2011 Mar 21.
• Background Rose PG, Ali S, Whitney CW, Lanciano R, Stehman FB. 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. 2010 May;117(2):270-5. doi: 10.1016/j.ygyno.2010.01.045. Epub 2010 Feb 24.
• Background Kunos C, Tian C, Waggoner S, Rose PG, Lanciano R. 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. 2009 Oct;19(7):1258-63. doi: 10.1111/IGC.0b013e3181b33ace.
• Background Gold MA, Tian C, Whitney CW, Rose PG, Lanciano R. Surgical versus radiographic determination of para-aortic lymph node metastases before chemoradiation for locally advanced cervical carcinoma: a Gynecologic Oncology Group Study. Cancer. 2008 May 1;112(9):1954-63. doi: 10.1002/cncr.23400.
• Background Monk BJ, Tian C, Rose PG, Lanciano R. 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. 2007 May;105(2):427-33. doi: 10.1016/j.ygyno.2006.12.027. Epub 2007 Feb 2.
• Background 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.
• Results Waggoner SE, Darcy KM, Tian C, Lanciano R. Smoking behavior in women with locally advanced cervical carcinoma: a Gynecologic Oncology Group study. Am J Obstet Gynecol. 2010 Mar;202(3):283.e1-7. doi: 10.1016/j.ajog.2009.10.884. Epub 2009 Dec 30.
• Results Waggoner SE, Darcy KM, Fuhrman B, Parham G, Lucci J 3rd, Monk BJ, Moore DH; Gynecologic Oncology Group. Association between cigarette smoking and prognosis in locally advanced cervical carcinoma treated with chemoradiation: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Dec;103(3):853-8. doi: 10.1016/j.ygyno.2006.05.017. Epub 2006 Jul 3.
• Results Lanciano R, Calkins A, Bundy BN, Parham G, Lucci JA 3rd, Moore DH, Monk BJ, O'Connor DM. Randomized comparison of weekly cisplatin or protracted venous infusion of fluorouracil in combination with pelvic radiation in advanced cervix cancer: a gynecologic oncology group study. J Clin Oncol. 2005 Nov 20;23(33):8289-95. doi: 10.1200/JCO.2004.00.0497. Epub 2005 Oct 17.
• Results Varia MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, Connelly P. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	40 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	225 mg/m2	Intravenous

Indications