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.

2023-505991-31-00 Protocol BIOMEC trial Therapeutic confirmatory (Phase III) Ended

Start 30 Apr 2024 · End 25 Jun 2024 · Status Ended · 1 EU/EEA countries · 4 sites · Protocol BIOMEC trial

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 1,037
Countries 1
Sites 4

ENDOMETRIAL CANCER

To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment

Key facts

Sponsor
Karolinska University Hospital
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
30 Apr 2024 → 25 Jun 2024
Decision date (initial)
2023-09-29
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment

Secondary objectives 7

  1. To assess recurrence free survival
  2. To assess Health Related Quality of Life
  3. To assess Lymphedema after sentinel lymphnode biopsy
  4. To assess Frailty
  5. To assess Sarcopenia
  6. To assess Health Economics
  7. To assess adverse events and postoperative complications

Conditions and MedDRA coding

ENDOMETRIAL CANCER

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Histologically confirmed primary carcinoma in the endometrium
  2. Women with presumed FIGO stage I-II
  3. Planned surgery with curative intent
  4. Patient must be suitable candidates for surgery
  5. Patient must be suitable candidates for adjuvant treatment
  6. ECOG performance status 0-2
  7. Patients who have signed an approved Informed Consent
  8. Age ≥ 18 years
  9. 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
  10. Women able to understand and comply with planned study procedures

Exclusion criteria 9

  1. FIGO stage > II pre- or peroperatively
  2. FIGO stage IIIA or IIIB or IV at final pathology
  3. Women with a history of pelvic or abdominal radiotherapy
  4. Women who are pregnant
  5. Women in whom surgery with palliative intent only is planned
  6. 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
  7. Women with iodine allergy cannot participate in the sentinel node part of the trial
  8. Women in whom macroscopic dissemination is suspected at preoperative imaging
  9. Women in whom macroscopic dissemination is confirmed during surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival

Secondary endpoints 7

  1. Recurrence-free survival
  2. EORTC QLQ-C30, QLQ-EN24 and EQ5D-5L Score
  3. LYMQOL and volume measurement, lymphosintigraphy result
  4. Clinical Frailty Scale-9 score (1-9)
  5. As measured by CT and applicable software (e.g., Coreslicer, Slice-o-matic etc.)
  6. QALY, cost per patient
  7. 30-day post-operative complications and adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
5 Other
Max total dose
5 Other
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
175 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

58 Total trials 31 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Karolinska University Hospital
Address
Eugeniavagen 3
City
Solna
Postcode
171 64
Country
Sweden

Scientific contact point

Organisation
Karolinska University Hospital
Contact name
Sahar Salehi

Public contact point

Organisation
Karolinska University Hospital
Contact name
Sahar Salehi

Locations

1 EU/EEA country · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ended 1,037 4
Rest of world — 0 —

Investigational sites

Sweden

4 sites · Ended
Linkoping University Hospital Region Ostergotland
Kvinnokliniken, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Avdelning för obstetrik och gynekologi, Bla Straket 5, 413 46, Goteborg
Norrlands University Hospital
Obstetrik och gynekologi, Umea Universitet, 901 85, Umea
Karolinska University Hospital
Department of Pelvic Cancer, Eugeniavagen 3, 171 64, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2024-04-30 2024-04-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of reults
SUM-74577
 2025-03-13T10:05:02 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Lay person summary of results 2025-03-13T10:05:59 Submitted Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) LAY PERSON SUMMARY 1
Summary of results (for publication) SUMMARY OF RESULTS 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-07-05 Sweden Acceptable
2023-09-28
 2023-09-29
2 SUBSTANTIAL MODIFICATION SM-1 2024-03-06 Sweden Acceptable
2024-04-08
 2024-04-19

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