Biomarker Guided Treatment in Gynaecological Cancer
Momatec2
1 other identifier
interventional
1,300
3 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2015
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2033
ExpectedMarch 28, 2017
March 1, 2017
5.2 years
July 7, 2015
March 24, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
number of recurrences after primary treatment
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.
5 year after diagnosis
stathmin levels
stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria
duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
Secondary Outcomes (2)
Quality of life measurements
5 years post treatment
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)
Study Arms (2)
phase 4 implementation study
EXPERIMENTALThe 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
EXPERIMENTALFor 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.
Interventions
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. Patients with endometrioid tumours grade 1 or 2, or grade 3 \<50% MI,, with either negative ER or PR status, are defined high risk and will undergo pelvic and para-aortic lymphadenectomy as part of their surgical procedure. Patients will receive routine clinical follow-up for 5 years. Follow-up data will be collected for the study, focusing on survival and recurrence of disease. All patients will, as part of the study fill out validated quality of life questionnaires (QoL) at follow-up.
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 defined as high with an immunohistochemical score 9 (max score). All other scores are considered low. Pre-treatment all patients undergo CT or MRI, maximum 1 month prior to treatment start. During treatment, urine and bloods will be collected every treatment cycle (weekly basis). Imaging will take place every 8 treatment cycles. Treatment will continue until disease progression.
Eligibility Criteria
You may qualify if:
- All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.
You may not qualify if:
- 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
- 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.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Radboud university hospital
Nijmegen, Netherlands
Women's hospital, Haukeland university hospital
Bergen, Hordaland, 5053, Norway
Ålesund hospital
Ålesund, 6017, Norway
Førde central hospital
Førde, 6812, Norway
Sørlandet hospital
Kristiansand, 4604, Norway
Akershus University hospital
Oslo, Norway
Stavanger university hospital
Stavanger, 4011, Norway
St Olav university hospital
Trondheim, 7006, Norway
Spsk No 1
Lublin, 20-081, Poland
Related Publications (1)
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.2021.08.011. Epub 2021 Aug 13.
PMID: 34400137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrica MJ Werner, MD PhD MRCOG
Haukeland University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
September 7, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2020
Study Completion (Estimated)
December 1, 2033
Last Updated
March 28, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share