2023-505991-31-00
Completed
Phase 3
BIOMarkers in Endometrial Cancer - A phase III open label randomized trial to determine the efficacy of biomarker staging as compared to conventional staging in women with presumed early-stage endometrial cancer (The BIOMEC trial)
Karolinska University Hospital4 sites in 1 country1,037 target enrollmentStarted: September 29, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Karolinska University Hospital
- Enrollment
- 1,037
- Locations
- 4
- Primary Endpoint
- Overall survival
Overview
Brief Summary
To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed primary carcinoma in the endometrium
- •Women able to understand and comply with planned study procedures
- •Women with presumed FIGO stage I-II
- •Planned surgery with curative intent
- •Patient must be suitable candidates for surgery
- •Patient must be suitable candidates for adjuvant treatment
- •ECOG performance status 0-2
- •Patients who have signed an approved Informed Consent
- •Age ≥ 18 years
- •Subject has adequate organ function, defined as follows: Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Creatinine ≤1.5 × ULN AST and ALT ≤2.5 x ULN
Exclusion Criteria
- •FIGO stage > II pre- or peroperatively
- •FIGO stage IIIA or IIIB or IV at final pathology
- •Women with a history of pelvic or abdominal radiotherapy
- •Women who are pregnant
- •Women in whom surgery with palliative intent only is planned
- •Women with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity
- •Women with iodine allergy cannot participate in the sentinel node part of the trial
- •Women in whom macroscopic dissemination is suspected at preoperative imaging
- •Women in whom macroscopic dissemination is confirmed during surgery
Outcomes
Primary Outcomes
Overall survival
Overall survival
Secondary Outcomes
- LYMQOL and volume measurement, lymphosintigraphy result
- Clinical Frailty Scale-9 score (1-9)
- As measured by CT and applicable software (e.g., Coreslicer, Slice-o-matic etc.)
- QALY, cost per patient
- 30-day post-operative complications and adverse events
- Recurrence-free survival
- EORTC QLQ-C30, QLQ-EN24 and EQ5D-5L Score
Investigators
Sahar Salehi
Scientific
Karolinska University Hospital
Study Sites (4)
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