A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopi… (NCT02489006) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Canada, New Zealand, Spain71 participantsStarted 2016-07-19
Plain-language summary
This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven recurrent high grade serous ovarian/primary peritoneal or fallopian tube cancer.
* Patients must have disease amenable to pre-operative biopsy.
* Patients must have disease deemed suitable for surgical debulking.
* Patients must have a progression free interval of at least 6 months prior to registration.
* Patients must have had at least one line of platinum based therapy.
* Patients must have shown platinum sensitivity to their last line of platinum therapy
* Age \>=18 years
* ECOG performance status 0-1 within 7 days of registration
* Life expectancy of greater than 3 months
* Patients must have normal organ and marrow function
* Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.
* Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
* History of allergic reactions attributed to platinum precluding further use.
* Radiation therapy within 4 weeks of registration
* Use of any other systemic, targeted, immunotherapy, chemotherapy, or investigational agents within 4 weeks of registration
* Previously received a PARP inhibitor
* Other malignancy within…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in levels of PAR or PARP-1 before and after study treatment
Timeframe: 4-8 weeks
2
Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue