Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

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. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

Timeline

Start

1993-12

Primary completion

2007-09

Completion

—

Outcome

Missed primary endpoint

paper We did not find a statistically significant advantage in recurrence rate or survival for adjuvant CIM over WAI in patients with uterine CS. PMID 17822748 ↗

paper The recurrence rate was 21% lower for CIM patients than for WAI patients (relative hazard [RH]=0.789, 95% confidence interval [CI]: (0.530-1.176), p=0.245, PMID 17822748 ↗

Publications

• Results Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Ifosfamide	Small molecule	—	Intravenous

Indications