Actively Recruiting
SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-04-22
42
Participants Needed
5
Research Sites
157 weeks
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
SOPRANO is a multi-centre, randomised phase II trial which aims to assess the impact of Stereotactic radiotherapy (SBRT) and 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.
CONDITIONS
Official 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
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Radiological progression while on or after prior PARP inhibitor therapy, which was the last systemic treatment
- At least 6 months of PARP inhibitor therapy as first-line or recurrent treatment
- Three or fewer lesions showing progression
- Each lesion less than 4 cm in axial diameter and suitable for SBRT
- Measurable disease by RECIST v1.1 on CT or MRI; patients with only CA125 progression without measurable disease are excluded
- No contraindications to restarting a PARP inhibitor
- Not planned for surgery for recurrent disease
- Adequate organ function to safely receive SBRT
- ECOG performance status of 0 or 1
- Predicted life expectancy of 6 months or more
- Women of child-bearing potential must have a negative pregnancy test within 72 hours before treatment start, or meet criteria for not being of child-bearing potential
- Willingness to follow scheduled visits, treatments, tests, and trial procedures
- Availability of histological tissue specimen before SBRT or willingness to undergo biopsy
- Ability to swallow, absorb, and retain oral medication
- Ability to provide written informed consent
You will not qualify if you...
- Medical conditions that make SBRT unsafe
- Brain metastases that are progressing or newly diagnosed and not suitable for surgery or radiosurgery; stable previously treated brain metastases allowed if stable for 6 months or more
- Prior radiotherapy near the target lesions that prevents safe SBRT
- Treatment with other investigational drugs within 4 weeks before trial entry
- Pregnancy or breastfeeding
- Women of childbearing potential unwilling to use highly effective contraception
- Unresolved toxicities from prior treatments greater than CTCAE Grade 1, except alopecia or chemotherapy-induced neuropathy
- Evidence or recent symptoms of bowel obstruction within 6 weeks before entry
- Other active or recently treated malignancies within 3 years, except non-melanoma skin cancer; confirmation of ovarian cancer progression required if prior malignancy treatment
- Investigator judgment that the patient is unsuitable or unlikely to comply with trial requirements
AI-Screening
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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
CONTACT
L
Laura Moretti
CONTACT
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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