Biomarker Guided Treatment in Gynaecological Cancer (Momatec2)

Haukeland University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Endometrial Cancer

Treatments: Drug: Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer; Procedure: Biomarker (ER/PR) guided lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02543710

2015/548

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria part 1:

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

Exclusion Criteria part 1:

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

Inclusion criteria part 2:

1. 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.
2. Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.

Exclusion criteria part 2:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

phase 4 implementation study

Experimental group

Description:

The historical MoMaTEC1 outcome data, collected from 2001-2015 serve as control arm. These data have been rigorously collected and quality controlled with extensive clinical annotation and follow-up data, and reflect the outcome in (for a larger part) the same population as expected for MoMaTEC2 as there have not been major changes in surgical or medical treatment for endometrial cancer in this time period that could cause confounding. Internal validity, and to a degree also external validity, covering practice in multiple countries, should in this way be assured.

Treatment:

Procedure: Biomarker (ER/PR) guided lymphadenectomy

phase 2b biomarker study

Experimental group

Description:

For the current study, stathmin is used as an integrated marker and does not dictate treatment modality, therefore there is no requirement for a control arm.

Treatment:

Drug: Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer