Biomarker Guided Treatment in Gynaecological Cancer

Phase 4

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Procedure: Biomarker (ER/PR) guided lymphadenectomy; Drug: Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer

• Registration Number: NCT02543710
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Study Start: 2015-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28
• Primary Completion: 2020-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
phase 4 implementation study	Biomarker (ER/PR) guided lymphadenectomy	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.
phase 2b biomarker study	Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer	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.

Primary Outcome Measures

Name	Time	Method
number of recurrences after primary treatment	5 year after diagnosis	The percentage of lymphadenectomy can be reduced safely and significantly, from 70% (MoMaTEC1 study results) to 30% in the MoMaTEC2 study through a better risk stratification of patients, especially better identification of low risk patients. Additionally The percentage of patients who need to be subjected to adjuvant (chemo) therapy can be reduced similarly from 20 to 10%, based on the same, optimised risk stratification and better identification of low risk patients. Patients will be rigorously followed during 5 years to detect any unexpected increase in the percentage of patients suffering a recurrence compared to the historical MoMaTEC1 cohort.
stathmin levels	duration of complete or partial treatment response in metastatic setting (expected duration less than one year)	stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Secondary Outcome Measures

Name	Time	Method
Quality of life measurements	5 years post treatment	Quality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24).
correlation of stathmin llevels in tumor, urine and blood	duration of complete or partial treatment response in metastatic setting (expected duration less than one year)	stathmin tumor levels, urine levels and blood levels will be correlated.

Trial Locations

Locations (9)

Ålesund hospital; 🇳🇴 Alesund, Norway

Sørlandet hospital; 🇳🇴 Kristiansand, Norway

Førde central hospital; 🇳🇴 Førde, Norway

Radboud university hospital; 🇳🇱 Nijmegen, Netherlands

Spsk No 1; 🇵🇱 Lublin, Poland

Stavanger university hospital; 🇳🇴 Stavanger, Norway

Akershus University hospital; 🇳🇴 Oslo, Norway

Women's hospital, Haukeland university hospital; 🇳🇴 Bergen, Hordaland, Norway

St Olav university hospital; 🇳🇴 Trondheim, Norway