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.
Key facts
- Where
- Goteborg, Linkoping, Solna és Umeå, SvédországSee the 4 sites
- Phase
- 3. fázis
Where in Svédország
- Sahlgrenska University Hospital-Vastra GotalandsregionenGoteborg, SvédországNo longer taking part
- Linkoping University Hospital Region OstergotlandLinkoping, SvédországNo longer taking part
- Karolinska University HospitalSolna, SvédországNo longer taking part
- Norrlands University HospitalUmeå, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- EU 2023-505991-31-00
- Record updated
- 2024. április 19.
- Original description
To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatmentRead full original descriptionShow less
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)
To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment
Inclusion: 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: Women in whom surgery with palliative intent only is planned; Women in whom macroscopic dissemination is confirmed during surgery; Women with a history of pelvic or abdominal radiotherapy; 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; FIGO stage > II pre- or peroperatively; FIGO stage IIIA or IIIB or IV at final pathology; Women who are pregnant; Women in whom macroscopic dissemination is suspected at preoperative imaging.