Sentinel Node Biopsy in Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQueensland Centre for Gynaecological Cancer
About this trial
Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients.
Primary Outcome Stage 1:
Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.
Primary Outcome Stage 2:
Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);
Clinically stage I disease (disease confined to body of uterus);
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2;
Signed written informed consent;
Disqualifiers
Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging.
Enlarged retroperitoneal pelvic and/or aortic lymph nodes (>1 cm) on medical imaging;
Estimated life expectancy of less than 6 months;
Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy;
Trial design
Design model
Parallel
Treatments tested in this trial
TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Procedure/SurgeryRemoval of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) +/- Methylene Blue Dye is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the "sentinel node". These one or two nodes are thought to be first involved with cancer spread.
TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Procedure/SurgeryRemoval of uterus, tubes and ovaries without retroperitoneal node dissection
Treatment groups
760 Participants
are divided into 2 treatment groupsGroup A: TH BSO with SNBExperimental treatment 1 intervention
Group B: TH BSO without retroperitoneal node dissectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stage 1: Return to usual activities
Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.
Time frame
12 months from surgery2
Stage 2: Disease Free Survival
Compare disease-free survival for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection
Time frame
4.5 years from surgerySecondary outcomes
1
Cost Effectiveness using QALYs using EuroQoL-5D (EQ-5D) Questionnaire
An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life. We will also measure the quality-adjusted life years (QALYs) gained with the intervention and use this to undertake a cost-utility analysis. The QALY calculations will be based on health status measures for trial participants, with valuations of changes in health status and quality of life based on the EQ-5D
Time frame
12 months from surgery2
Cost Effectiveness measuring Intervention costs
An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society.
Time frame
12 months from surgery3
Cost Effectiveness measuring GP and specialist consultations
An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life.
Time frame
12 months from surgery4
Cost Effectiveness measuring radiology and imaging requirements
An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society.
Time frame
12 months from surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Queensland Centre for Gynaecological Cancer
Lead sponsor
The University of Queensland
Collaborator
Source ClinicalTrials.gov