Actively Recruiting
SOPRANO: Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-04-22
42
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
R
Royal Marsden NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of stereotactic radiotherapy (SBRT) and ongoing treatment with a PARP inhibitor (PARPi) in women with ovarian, fallopian tube, or primary peritoneal cancer who have limited sites of tumor growth called oligometastatic or oligoprogressive disease. The trial focuses on patients whose cancer has progressed on or after at least six months of PARPi therapy. It explores whether targeting resistant tumor areas with SBRT, followed by continuation of a PARPi drug called niraparib, can control disease that remains sensitive to treatment. This phase II trial also looks at how feasible and acceptable delivering SBRT is in this setting. Participants will be randomly assigned to one of two groups: one receiving SBRT followed by niraparib and the other receiving SBRT alone. SBRT treatment starts within seven days after randomization and involves a course of radiation delivered in 3 to 8 sessions over 5 to 19 days, tailored to tumor location. In the group receiving niraparib, this oral medication begins four weeks after SBRT and continues daily until the disease progresses or treatment is stopped for other reasons. During the study, participants will have regular assessments including scans every 8 weeks during the first year and every 12 weeks after to monitor disease status using RECIST criteria. Researchers will collect information on side effects, quality of life, and survival outcomes up to two years post-randomization. The main outcome measured is progression-free survival at six months, with additional outcomes including time to other therapies, overall survival, local tumor control, and treatment feasibility. Consent for future health data linkage is also requested to track long-term health status and any new conditions.
CONDITIONS
Brief Title
SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Radiological disease progression while on or after prior PARP inhibitor therapy, with PARPi as last systemic treatment
- At least 6 months of PARP inhibitor therapy as first line or for recurrent disease
- Three or fewer progressive lesions
- Each lesion must be less than 4 cm in diameter and suitable for stereotactic radiotherapy
- Measurable disease by RECIST criteria v1.1 assessed by CT or MRI
- No contraindication to restarting a PARP inhibitor
- No planned surgery for recurrent disease
- Adequate organ function to allow stereotactic radiotherapy
- ECOG performance status of 0 or 1
- Predicted life expectancy of at least 6 months
- Women of child-bearing potential must have a negative pregnancy test or be confirmed not of child-bearing potential
- Willing to follow scheduled visits, treatments, laboratory tests, and trial procedures
- Histological tissue specimen available before starting stereotactic radiotherapy
- Able to swallow, absorb, and retain oral medication
- Able to provide written informed consent
You will not qualify if you...
- Co-morbidities that prevent safe use of stereotactic radiotherapy
- Progressing or new brain metastases not suitable for surgery or radiosurgery
- Prior radiotherapy near lesions preventing ablative stereotactic radiotherapy
- Treatment with other investigational drugs within 4 weeks before trial entry
- Pregnant or breastfeeding women
- Women of childbearing potential unwilling to use effective contraception
- Unresolved toxicities from prior therapy greater than Grade 1 except alopecia or neuropathy
- Evidence or symptoms of bowel obstruction within 6 weeks prior to trial entry
- Other active or treated malignancies within 3 years except non-melanoma skin cancer
- Investigator judgment deeming patient unsuitable or unlikely to comply with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - SBRT lasts 5 to 19 days; niraparib continues until disease progression or discontinuation
Participants receive stereotactic radiotherapy (SBRT) targeting up to three lesions over 3 to 8 treatment sessions spanning 5 to 19 days. Depending on the assigned cohort, participants either start daily oral niraparib about 4 weeks after completing SBRT and continue until disease progression or other discontinuation criteria, or receive SBRT alone.
SBRT delivered over 3 to 8 fractions; niraparib taken daily with regular assessments
Duration - Up to 2 years post randomization
Participants undergo disease assessments every 8 weeks for the first year following SBRT, then every 12 weeks thereafter until disease progression. Quality of life and toxicity are monitored throughout the trial period, which may last up to 2 years post randomization.
Assessments every 8 weeks for 1 year, then every 12 weeks thereafter
Trial Site Locations
Total: 5 locations
1
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Actively Recruiting
2
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
3
University College London Hospitals
London, UK, United Kingdom, NW1 2PG
Actively Recruiting
4
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
5
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
L
Lorna Smith
L
Laura Moretti
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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