Signal TrAnsduction Pathway activity analysis for OVarian cancER treatment. STAPOVER study
- Conditions
- Cancer of the ovaryovarian carcinoma1003859410033283
- Registration Number
- NL-OMON50803
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 148
- Age 18 years or older
- Patients with recurrent ovarian cancer who meet one of the following criteria:
1. Platinum-resistant disease or;
2. Patients refrains from standard therapy or;
3. Asymptomatic patients who are not yet eligible for standard palliative
chemotherapy but have an increase of CA125 tumour marker at two consecutive
timepoints 28 days apart with a value of two times nadir above 35 U/ml).
- Progressive disease after at least one prior line of systemic treatment for
recurrent disease.
- Radiologically evaluable disease according to RECIST 1.1 criteria.
- Ability and willingness to obtain a tumour biopsy after the last course of
standard treatment and before start of the study.
- Ability and willingness to provide written and oral consent.
- Able to speak and understand the Dutch language.
- WHO performance status 0-II.
- Adequate renal and liver function to start matched targeted therapy
(according to the local clinician).
- Adequate use of contraceptives in case of patients with childbearing
potential.
- Age < 18 years.
- Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or
targeted drug or radiation) or is chemotherapy naïve. The required wash out
period prior to start of matched targeted therapy is at least three weeks.
- Patient is diagnosed with or treated for a second primary tumour (except
non-melanoma skin tumour) one year prior to study inclusion.
- Inability to obtain (sufficient) tumour material.
- Previous use of the selected targeted drug as anti-cancer agent.
- Physical condition WHO III-IV.
- Pregnant or lactating women.
- Contra-indication for the use of the matched targeted therapy.
- Simultaneous participation in another treatment-related clinical trial.
- Patients with any other clinically significant medical condition which, in
the opinion of the local clinician, makes it undesirable for the patient to
participate in this study or which could jeopardize compliance with study
requirements including, but not limited to: ongoing or active infection, severe
psychiatric illness, or complicated social situations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is therapy response defined as PFS2/PFS1 ratio according to<br /><br>RECIST 1.1 criteria.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes include the proportion of patients with an actionable active<br /><br>pathway and the proportion of patients receiving matched targeted therapy, best<br /><br>overall response (according to RECIST 1.1 criteria), one-year overall survival<br /><br>and overall survival, predictive value of STA-analysis results, side effects,<br /><br>quality of life, cost-effectiveness and change in pathway activity score after<br /><br>disease progression compared to the pathway activity score before the start of<br /><br>targeted therapy. </p><br>