Biomarker Guided Treatment in Gynaecological Cancer

NCT02543710RecruitingPHASE4INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Haukeland University Hospital

Enrollment

1300

Start Date

2015-10-01

Completion Date

2020-12-01

Study Type

INTERVENTIONAL

Official Title

Biomarker Guided Treatment in Gynaecological Cancer

Interventions

Biomarker (ER/PR) guided lymphadenectomyBiomarker guided weekly taxane treatment in endometrial/ ovarian cancer

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years – 95 Years

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

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.

Time frame: 5 year after diagnosis

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

Time frame: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)

Secondary Outcomes

Quality of life measurements

Quality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24).

Time frame: 5 years post treatment

correlation of stathmin llevels in tumor, urine and blood

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)

Locations

Radboud university hospital, Nijmegen, Netherlands

Women's hospital, Haukeland university hospital, Bergen, Norway

Ålesund hospital, Ålesund, 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, Norway

Spsk No 1, Lublin, Poland

Biomarker Guided Treatment in Gynaecological Cancer