Biomarker Guided Treatment in Gynaecological Cancer

Overview

MoMaTEC2 aims to test, in clinically oriented studies, the applicability of already identified and promising molecular biomarkers, to promote individualisation of treatment for patients with endometrial cancer. Predominantly, but not exclusively, such biomarkers have shown to be interesting in retrospective analysis of our large prospectively collected MoMaTEC1 series. Part 1: Performance of a phase 4 implementation trial for optimised stratification of surgical treatment, specifically the performance of (para-aortic and pelvic) lymphadenectomy guided by validated biomarkers. Part 2: Performance of a phase 2b clinical biomarker study to evaluate the predictive potential of the biomarker stathmin for taxane treatment response in endometrial and ovarian cancer. In this study stathmin will be used as integrated biomarker.

Interventions

• Procedure Biomarker (ER/PR) guided lymphadenectomy
  Lymphadenectomy in the pelvis and para-aortic, will, for patients who are considered otherwise low risk (endometrioid tumours grade 1 or 2, or grade 3 with \<50% myometrial infiltration (MI), with no sign of extrauterine disease), be dependent on the preoperative hormone receptor status (ER and PR). Patients will be defined low risk when endometrioid, grade 1 or 2, or grade 3 with \<50% MI, AND positive hormone receptor status for both ER AND PR. These patients will not undergo lymphadenectomy.
• Drug Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer
  A 5mm tissue biopsy will be analysed for stathmin level in the recurrence as well as urine and a second 5mm biopsy on termination of study participation. The second biopsy could help explain why patients have stopped responding to the treatment. Determination of stathmin level both from the tissue and the urine will take place at the pathology department. Stathmin serves as an integrated biomarker, which enables a central biomarker analysis at Haukeland university hospital. Stathmin level is def

Primary outcome measures

• number of recurrences after primary treatment [Time frame: 5 year after diagnosis]
• stathmin levels [Time frame: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)]

Secondary outcome measures (2)

• Quality of life measurements [Time frame: 5 years post treatment]
• correlation of stathmin llevels in tumor, urine and blood [Time frame: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)]

Eligibility criteria

Inclusion Criteria part 1:

All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.

Exclusion Criteria part 1:

• Patients who do not have endometrial cancer
• Patients who will or cannot give informed consent (including language barriers)
• Patients <18 years of age
• Patients who will not get surgical treatment for their endometrial cancer

Inclusion criteria part 2:

• Patients with endometrial or epithelial ovarian cancer who following routine clinical guidelines are offered weekly taxane (paclitaxel) treatment. This will often be a third or fourth line treatment, i.e. patients with advanced disease.
• Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.

Exclusion criteria part 2:

• Patients not suffering from endometrial or epithelial ovarian cancer
• Patients <18 years of age
• Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre
• Patients who cannot or do not want to give informed consent (including language barriers)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 7 centers

• Women's hospital, Haukeland university hospital — Bergen
• Ålesund hospital — Ålesund
• Førde central hospital — Førde
• Sørlandet hospital — Kristiansand
• Akershus University hospital — Oslo
• Stavanger university hospital — Stavanger
• St Olav university hospital — Trondheim

Netherlands · 1 center

• Radboud university hospital — Nijmegen

Poland · 1 center

• Spsk No 1 — Lublin

Publications

• Forsse D, Barbero ML, Werner HMJ, Woie K, Nordskar N, Berge Nilsen E, Ellstrom Engh M, Vistad I, Rege A, Saevik-Lode M, Andreasen S, Haldorsen IS, Trovik J, Krakstad C. Longitudinal effects of adjuvant chemotherapy and lymph node staging on patient-reported outcomes in endometrial cancer survivors: a prospective cohort study. Am J Obstet Gynecol. 2022 Jan;226(1):90.e1-90.e20. doi: 10.1016/j.ajog.2 PMID 34400137

Identifiers

NCT: NCT02543710 · 2015/548

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗