SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Fol… (NCT05990192) | Clinical Trial Compass
RecruitingPhase 2
SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
United Kingdom42 participantsStarted 2024-06-20
Plain-language summary
SOPRANO is a multi-centre phase II trial designed to assess the impact of SBRT with or without continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.
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
. Patients ≥ 18 years of age.
. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report includes immunohistochemistry confirming ovarian cancer, patient should not be excluded).
. Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is required to have been the patient's last systemic therapy.
. Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease.
. ≤3 lesions of progressive disease.
. Each lesion to undergo SBRT \<4 cm axial diameter, and feasible for SBRT as discussed in the SOPRANO virtual MDT (vMDT) meeting.
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
Progression free survival
Timeframe: The primary timepoint of most interest for PFS is at six months after trial entry
Trial details
NCT IDNCT05990192
SponsorInstitute of Cancer Research, United Kingdom
. Measurable disease by RECIST criteria v1.1, which can be accurately assessed at baseline by CT or MRI. Patients with CA125 progression in the absence of measurable disease will NOT be eligible. The following is an exception to this criterion: Lymph nodes with a short-axis diameter ≥10 mm may be included when there is clear evidence of malignancy (e.g., PET-positive nodes and radiologically progressive disease), acknowledging that clinically significant nodal disease may occur below the standard RECIST threshold.
. No contra-indication to restarting a PARP inhibitor.
Exclusion criteria
. Co-morbidities which would preclude the safe use of SBRT.
. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or stereotactic radiosurgery. Previously treated brain metastases (i.e. palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for ≥ 6 months are permissible.
. Prior radiotherapy near the oligometastatic / oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in Section 6.1 of this document and will be determined by the SOPRANO virtual MDT.
. Treatment with any other investigational medicinal product (IMP) within the 4 weeks prior to trial entry.
. Pregnant or lactating women.
. Women of childbearing age and potential who are not willing to use a highly effective contraceptive measure.
. Any unresolved toxicities from prior therapy should be no greater than CTCAE Grade 1 with the exception of Grade 2 alopecia or chemo-induced neuropathy at trial entry.
. Clinical/radiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry.