Biomarker Guided Treatment in Gynaecological Cancer (Momatec2)
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|ClinicalTrials.gov Identifier: NCT02543710|
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : March 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Procedure: Biomarker (ER/PR) guided lymphadenectomy Drug: Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Guided Treatment in Gynaecological Cancer|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2033|
Experimental: phase 4 implementation study
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.
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.
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.
Experimental: phase 2b biomarker study
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.
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 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.
- number of recurrences after primary treatment [ Time Frame: 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 [ Time Frame: 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
- Quality of life measurements [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543710
|Contact: Jone Trovik, MD PhD Profemail@example.com|
|Contact: Henrica MJ Werner, MD PhD MRCOGfirstname.lastname@example.org|
|Radboud university hospital||Not yet recruiting|
|Contact: Hanny MA Pijnenborg, MD, PhD|
|Contact: Casper Reijne, MD|
|Women's hospital, Haukeland university hospital||Recruiting|
|Bergen, Hordaland, Norway, 5053|
|Contact: Henrica MJ Werner, MD, PhD +4755974200 email@example.com|
|Contact: Jone Trovik, prof MD PhD +4755974200 firstname.lastname@example.org|
|Alesund, Norway, 6017|
|Contact: Margaret S Lode, MD|
|Førde central hospital||Recruiting|
|Førde, Norway, 6812|
|Contact: Jostein Tjugum, MD|
|Contact: marthe LT Larsson, MD|
|Sørlandet hospital||Not yet recruiting|
|Kristiansand, Norway, 4604|
|Contact: Ane C Munk, MD, PhD|
|Contact: ingvild Vistad, MD, PhD|
|Akershus University hospital||Recruiting|
|Contact: marie E Engh, MD|
|Stavanger university hospital||Recruiting|
|Stavanger, Norway, 4011|
|Contact: Elisabeth B Nilsen, MD|
|St Olav university hospital||Recruiting|
|Trondheim, Norway, 7006|
|Contact: Nina Nordskar, MD|
|Contact: Solveig Tingulstad, MD|
|Spsk No 1||Recruiting|
|Lublin, Poland, 20-081|
|Contact: Bartolomiej Barczynski, MD, PhD|
|Principal Investigator:||Henrica MJ Werner, MD PhD MRCOG||Haukeland University Hospital|