Simple Hysterectomy And Pelvic node dissection in Early cervix cancer
Research type
Research Study
Full title
A randomized phase III trial comparing radical hysterectomy and pelvic node dissection versus simple hysterectomy and pelvic node dissection in patients with low-risk early-stage cervical cancer (SHAPE)
IRAS ID
141368
Contact name
J A Tidy
Contact email
Sponsor organisation
NCIC Clinical Trials Group
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Cervical cancer is the second most common worldwide cause of female cancer deaths. In the UK in 2010, there were 3500 cases and 940 deaths. Screening has reduced the incidence in the UK but the proportion of young women presenting with low-risk early stage disease has increased. The current standard of care for these patients is a radical hysterectomy with pelvic lymph node dissection, the cure rate is high but women are at risk of suffering "survivorship" issues related to long term surgical effects such as compromised sexual, bowel and bladder function, as well as infertility. It is unclear whether less radical surgery, which has a lower morbidity is as effective, as well as there being a lack of high-quality evidence upon which clinicians can base their decisions and advise their patients. The answers to these questions will be determined by a randomised international trial. The SHAPE trial will address whether a simple hysterectomy with pelvic node dissection in patients with previously untreated, low-risk, early-stage cervical cancer is of similar benefit to a radical hysterectomy with pelvic node dissection with respect to preventing the cancer returning. The definition of early-stage, low-risk cervical cancer is based on the International Federation of Gynaecology and Obstetrics (FIGO) staging classification schema, and includes early stage IA2 patients and a subset of those with stage IB1 disease (cervical cancer confined to within the cervix). Secondary endpoints include extra pelvic relapse-free survival, overall survival, toxicity and patient reported outcomes. The latter endpoint is of particular importance, therefore survivorship issues with regards to quality of life and sexual function will be addressed given the short and long term side effects associated with a radical hysterectomy. Health economics will also be evaluated given that a simple hysterectomy should be associated with fewer post-operative and long-term management requirements.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1108
Date of REC Opinion
9 Oct 2014
REC opinion
Further Information Favourable Opinion