Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarker Guided Treatment in Gynaecological Cancer (Momatec2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02543710
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jone Trovik, MD PhD Prof +4755974200 jone.trovik@k2.uib.no
Contact: Henrica MJ Werner, MD PhD MRCOG +4755974200 henrica.werner@k2.uib.no

Locations
Layout table for location information
Netherlands
Radboud university hospital Not yet recruiting
Nijmegen, Netherlands
Contact: Hanny MA Pijnenborg, MD, PhD         
Contact: Casper Reijne, MD         
Norway
Women's hospital, Haukeland university hospital Recruiting
Bergen, Hordaland, Norway, 5053
Contact: Henrica MJ Werner, MD, PhD    +4755974200    heaw@helse-bergen.no   
Contact: Jone Trovik, prof MD PhD    +4755974200    jone.trovik@uib.no   
Ålesund hospital Recruiting
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
Oslo, Norway
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         
Poland
Spsk No 1 Recruiting
Lublin, Poland, 20-081
Contact: Bartolomiej Barczynski, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Henrica MJ Werner, MD PhD MRCOG Haukeland University Hospital

Layout table for additonal information
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02543710    
Other Study ID Numbers: 2015/548
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Taxane
Antineoplastic Agents