RecruitingPhase 4NCT02543710

Biomarker Guided Treatment in Gynaecological Cancer

Sponsor

Haukeland University Hospital

Enrollment

1,300 participants

Start Date

Oct 1, 2015

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether levels of a specific protein (called stathmin) in tumor tissue can predict how well women with uterine (endometrial) or ovarian cancer will respond to a chemotherapy drug called paclitaxel (taxane), with the goal of personalizing cancer treatment. **You may be eligible if...** - Part 1: You have been referred to a participating hospital with suspected or confirmed endometrial (uterine) cancer and are planning to have surgery - Part 2: You have endometrial or ovarian cancer and your doctor has recommended weekly paclitaxel (taxane) treatment as a later line of therapy, and it is possible to get a new tissue biopsy - You are 18 years of age or older - You are able to give informed consent **You may NOT be eligible if...** - You do not have endometrial or ovarian cancer - You are under 18 years old - You are unable or unwilling to give consent (including due to language barriers) - You are not having surgery for your cancer (Part 1), or you are receiving treatment at a non-participating center (Part 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiomarker (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.

DRUGBiomarker 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.