Biomarker Guided Treatment in Gynaecological Cancer

Endometrial Cancer Clinical Trial

— Momatec2  

Official title:

Biomarker Guided Treatment in Gynaecological Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543710
• Other study ID #: 2015/548
• Status: Recruiting
• Phase: Phase 4
• First received: July 7, 2015
• Last updated: March 24, 2017
• Start date: October 2015
• Est. completion date: December 2033

Study information

• Verified date: March 2017
• Source: Haukeland University Hospital
• Contact: Jone Trovik, MD PhD Prof
• Phone: +4755974200
• Email: jone.trovik[@]k2.uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 2033
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.

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.

Locations

Country	Name	City	State
Netherlands	Radboud university hospital	Nijmegen
Norway	Ålesund hospital	Alesund
Norway	Women's hospital, Haukeland university hospital	Bergen	Hordaland
Norway	Førde central hospital	Førde
Norway	Sørlandet hospital	Kristiansand
Norway	Akershus University hospital	Oslo
Norway	Stavanger university hospital	Stavanger
Norway	St Olav university hospital	Trondheim
Poland	Spsk No 1	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Countries where clinical trial is conducted

Netherlands,  Norway,  Poland, 

Outcome

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