ELIGIBILITY CRITERIA- Summarised A randomised 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 TRIAL DESIGN SAMPLE SIZE RATIONALE 700 patients internationally Predicted recruitment time = 3 1/2 years Randomisation As a result of effective screening in developed countries, the proportion of younger women presenting with low-risk early-stage disease has increased. Surgical therapy is highly efficacious in providing durable disease control in these patients, however they are at risk of suffering “survivorship” issues related to long-term surgical effects, including compromised sexual, bowel and bladder function, as well as infertility. ELIGIBILITY CRITERIA- Summarised INCLUSION: Histological confirmed adenocarcinoma, squamous or adenosquamous cancer of the cervix FIGO Stage 1A2 or 1B1 Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after initial diagnostic procedure and prior to randomisation. Chest X-Ray or CT scan of chest AND pelvic MRI (pelvic MRI is optional if the patient has stage IA2 disease and underwent a LEEP or cone) Suitable for surgery No desire to preserve fertility Willing to complete the Quality of Life Questionnaire Written informed consent Able to comply with protocol treatment and follow up Surgery to be completed within 20 weeks of initial diagnosis ≥18 years of age EXCLUSION: Patients with FIGO IA1 disease History of other malignancies (see protocol for exceptions) Evidence of lymph node metastasis Patients who have had or will receive neoadjuvant chemotherapy Patients who are pregnant Control Arm Radical Hysterectomy with pelvic node dissection +/- Sentinel node mapping* Experimental Arm Simple Hysterectomy with pelvic node dissection +/- Sentinel node mapping* PRIMARY ENDPOINT Pelvic relapse-free survival SECONDARY ENDPOINTS To compare the two treatment arms with respect to: Extrapelvic relapse-free survival Relapse-free survival (any site) Overall survival Treatment-related adverse events Patient-reported outcomes including global quality of life and measures of sexual health Cost-effectiveness and cost-utility To observe rates of the following in this patient population: sentinel node detection, parametrial involvement, involvement of surgical margins, pelvic node involvement Protocol mandated follow up * Regardless of treatment assignment, surgery will include pelvic lymph node dissection with optional sentinel lymph node (SN) mapping. If SN mapping is to be done, the mode is optional, but the laparoscopic approach is preferred. Trial Contact: ctc.SHAPE@ucl.ac.uk UK Lead Investigator: Professor John Tidy Sponsor: NCIC Clinical Trials Group (Canada) UK Coordination: CRUK & UCL Cancer Trials Centre DURATION OF PATIENT FOLLOW UP Following surgery, patients will be seen: 3-monthly in year one 4-monthly in year two 6-monthly in year three Annually thereafter until study closure SHAPE Summary v2.0 dated 18.11.2014