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Biomarker Guided Treatment in Gynaecological Cancer (Momatec2)

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Biomarker (ER/PR) guided lymphadenectomy
Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Radboud university hospital
  • Women's hospital, Haukeland university hospitalRecruiting
  • Ålesund hospitalRecruiting
  • Førde central hospitalRecruiting
  • Sørlandet hospital
  • Akershus University hospitalRecruiting
  • Stavanger university hospitalRecruiting
  • St Olav university hospitalRecruiting
  • Spsk No 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

phase 4 implementation study

phase 2b biomarker study

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Quality of life measurements
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
stathmin tumor levels, urine levels and blood levels will be correlated.

Full Information

First Posted
July 7, 2015
Last Updated
March 24, 2017
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02543710
Brief Title
Biomarker Guided Treatment in Gynaecological Cancer
Acronym
Momatec2
Official Title
Biomarker Guided Treatment in Gynaecological Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
phase 4 implementation study
Arm Type
Experimental
Arm 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.
Arm Title
phase 2b biomarker study
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biomarker (ER/PR) guided lymphadenectomy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer
Intervention Description
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 Measure Information:
Title
number of recurrences after primary treatment
Description
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.
Time Frame
5 year after diagnosis
Title
stathmin levels
Description
stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Time Frame
duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
Secondary Outcome Measure Information:
Title
Quality of life measurements
Description
Quality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24).
Time Frame
5 years post treatment
Title
correlation of stathmin llevels in tumor, urine and blood
Description
stathmin tumor levels, urine levels and blood levels will be correlated.
Time Frame
duration of complete or partial treatment response in metastatic setting (expected duration less than one year)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria part 1: All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer. Exclusion Criteria part 1: 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 Inclusion criteria part 2: 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. Exclusion criteria part 2: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jone Trovik, MD PhD Prof
Phone
+4755974200
Email
jone.trovik@k2.uib.no
First Name & Middle Initial & Last Name or Official Title & Degree
Henrica MJ Werner, MD PhD MRCOG
Phone
+4755974200
Email
henrica.werner@k2.uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrica MJ Werner, MD PhD MRCOG
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university hospital
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanny MA Pijnenborg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Casper Reijne, MD
Facility Name
Women's hospital, Haukeland university hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5053
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrica MJ Werner, MD, PhD
Phone
+4755974200
Email
heaw@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Jone Trovik, prof MD PhD
Phone
+4755974200
Email
jone.trovik@uib.no
Facility Name
Ålesund hospital
City
Alesund
ZIP/Postal Code
6017
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret S Lode, MD
Facility Name
Førde central hospital
City
Førde
ZIP/Postal Code
6812
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jostein Tjugum, MD
First Name & Middle Initial & Last Name & Degree
marthe LT Larsson, MD
Facility Name
Sørlandet hospital
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ane C Munk, MD, PhD
First Name & Middle Initial & Last Name & Degree
ingvild Vistad, MD, PhD
Facility Name
Akershus University hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marie E Engh, MD
Facility Name
Stavanger university hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth B Nilsen, MD
Facility Name
St Olav university hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Nordskar, MD
First Name & Middle Initial & Last Name & Degree
Solveig Tingulstad, MD
Facility Name
Spsk No 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartolomiej Barczynski, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34400137
Citation
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.
Results Reference
derived

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Biomarker Guided Treatment in Gynaecological Cancer

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