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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Canadian Cancer Trials Group
- Enrollment
- 700
- Locations
- 85
- Primary Endpoint
- Pelvic Recurrence Rate at 3 Years
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist.
- •Patient has been classified as low-risk early-stage cervical cancer. These patients include:
- •FIGO Stage IA2 \[FIGO Annual Report, 2009\], defined as:
- •o evidence of disease by microscopy;
- •for patients who underwent a LEEP or cone:
- •histologic evidence of depth of stromal invasion \> 3.0 and ≤ 5.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen NB: the maximum depth of stromal invasion must be ≤ 10 mm.
- •histologic evidence of lateral extension that is ≤ 7.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen; and
- •negative margins (patients with positive margins are considered IB1, see below)
- •for patients who underwent a cervical biopsy only:
- •radiologic evidence of less than 50% stromal invasion based on pelvic MRI
Exclusion Criteria
- •Patients with FIGO 1A1 disease \[FIGO Annual Report, 2009\].
- •History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin's lymphoma or non-Hodgkin's lymphoma curatively treated with no evidence of disease for \> 5 years.
- •Patients with evidence of lymph node metastasis on preoperative imaging or histology.
- •Patients who have had or will receive neoadjuvant chemotherapy.
- •Patients who are pregnant.
- •Patients for whom adjuvant radiation and/or chemotherapy is planned.
Outcomes
Primary Outcomes
Pelvic Recurrence Rate at 3 Years
Time Frame: 3 years
Pelvic recurrence rate at 3 years was estimated by 1-the Kaplan-Meier estimate for the probability of pelvic relapse free survival (PRFS) at 3 years. PRFS was defined as the time from randomization to the time when a recurrence within the pelvic field was first documented. Patients who had a relapse outside of the pelvic field documented or died before the documentation of a pelvic relapse were censored at the time of first documented extra-pelvic relapse or death. The pelvic relapse free survival of patients who were alive without any relapse at the time of final analysis was censored at the last known alive.
Secondary Outcomes
- Pelvic Relapse-free Survival(3 years)
- Extra-pelvic Relapse-free Survival(3 years)
- Relapse-free Survival(3 years)
- Overall Survival(3 years)