Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 75 years of age.
• People whose general health and ability to carry out daily activities falls within an acceptable range as measured by a standard oncology scoring system (confirm with trial site).
• People who have a type of ovarian, peritoneal, or fallopian tube cancer that came back after treatment, and whose cancer previously responded well to platinum-based chemotherapy.
• People whose first or second course of treatment may have included a maintenance therapy such as bevacizumab or a PARP inhibitor drug.
• Depending on which group (cohort) a person is assigned to, eligibility differs based on whether or not a PARP inhibitor was previously used, and whether or not surgery was performed at the time of the first recurrence (confirm with trial site which cohort applies).
• People whose cancer has been assessed by experienced surgeons as being fully removable through surgery, based on scans such as CT, MRI, or PET/CT.
• People with a single lesion outside the abdominal cavity that surgeons believe can be fully removed.
• People with no more than 3 disease lesions confirmed by centrally reviewed PET/CT imaging, if the participating centre has not previously taken part in surgical trials for ovarian cancer.
• People who have given their written informed consent to participate.

Who may not be able to join:

• People whose tumour type is classified as borderline or non-epithelial.
• People for whom the planned surgery is interval debulking, a second- or third-look procedure, or palliative (comfort-focused) surgery.
• People whose cancer cannot be properly assessed for surgical removal, or where scans suggest complete removal is not possible.
• People who have received more than two previous courses of chemotherapy (note: maintenance therapy is not counted as an additional course).
• People whose cancer has come back for a third time or more.
• People who have a second or other type of cancer that was treated with surgery, if that treatment could interfere with treating the ovarian cancer or is expected to significantly affect outlook.
• People whose cancer progressed during chemotherapy, or came back within 6 months of completing a second course of platinum-based chemotherapy.
• People for whom surgery, chemotherapy, or the study drug Niraparib is medically unsuitable for any reason.
• People with serious chronic lung disease accompanied by low oxygen levels.
• People with uncontrolled high blood pressure, a history of stroke, recent heart attack, unstable chest pain, untreated blood clots, ongoing heart failure, or a serious heart rhythm problem requiring medication.
• People with severe liver disease, liver inflammation, kidney disease affecting protein levels, or significant kidney impairment.
• People with active stomach ulcers, openings or tears in the gut wall, abdominal abscess, or who are currently receiving treatment to prevent or manage ulcers.
• People with uncontrolled diabetes.
• People with uncontrolled epilepsy requiring long-term anti-seizure medication.
• People taking medications that could significantly increase the risk of bleeding during surgery, such as oral blood thinners.
• People who experienced severe anaemia, very low white blood cell counts, or very low platelet counts due to chemotherapy, lasting more than 4 weeks (confirm grading details with trial site).
• People who have a known allergy or sensitivity to Niraparib or any of its ingredients.

Important: Always verify eligibility with the trial site directly before applying.