Surgery With or Without Chemotherapy in Treating Patients With Stage IB Cervical Cancer

Phase 3 Completed Gynecologic Oncology Group National Cancer Institute (NCI) · collab

Treatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase III trial to compare surgery with or without chemotherapy in treating patients who have stage IB cervical cancer.

Timeline

Start: 1996-12
Primary completion: 2007-08
Completion: —

Outcome

Missed primary endpoint

paper The NACT+RHPPL group had very similar recurrence rates (relative risk: 0.998) and death rates (relative risk: 1.008) when compared to the RHPPL group. PMID 17493669 ↗

paper There is no evidence from this trial that NACT offered any additional objective benefit to patients undergoing RHPPL for suboptimal Stage IB cervical cancer. PMID 17493669 ↗

Publications

Results Eddy GL, Bundy BN, Creasman WT, Spirtos NM, Mannel RS, Hannigan E, O'Connor D. Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: a phase III trial of the gynecologic oncology group. Gynecol Oncol. 2007 Aug;106(2):362-9. doi: 10.1016/j.ygyno.2007.04.007. Epub 2007 May 9.

Drugs

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