Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-risk Early Stage Cervical Cancer (SHAPE)

Official Title

A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE)

Summary:

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

Trial Description

Primary Outcome:

• Pelvic relapse-free survival

Secondary Outcome:

• Efficacy comparison between treatment arms

At this time, it is not clear which of these approaches best balances the desire to prevent cancer of the cervix from returning with the risks of side effects after surgery and in the long-term.

View this trial on ClinicalTrials.gov