At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Niraparib oral capsule (drug), SBRT (radiation)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- Niraparib oral capsule — drug: Niraparib used following SBRT treatment until disease progression · SBRT — radiation: SBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 42
- Started
- 2024-06-20
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian cancer recurrent
- • Phase2 - 42 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ovarian cancer recurrent
- • Female only
Where?
- • Leeds - St James's University Hospital
- • Leicester - Leicester Royal Infirmary
- • Manchester - The Christie NHS Foundation Trust
- • Edinburgh - Western General Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Oligometastases or oligoprogression of ovarian cancer while on a PARPi may occur due to a secondary sub-clonal mutation causing acquired resistance in a small volume of tumour rather than having global tumour resistance. Eradication of the resistant disease with stereotactic radiotherapy (SBRT) would enable continuation of the PARPi to maintain control of disease that has retained drug sensitivity and this has the potential to impact disease outcomes. For the purposes of this ovarian cancer trial, oligoprogression refers to the situation whereby 3 or less lesions of disease show evidence of progression. If there were previously other sites of disease, these remain in response or stable. Oligometastatic disease refers to the situation whereby complete response to treatment has been obtained and the disease relapse occurs that is limited in number and distribution (≤3 metastatic/recurrent lesions). SOPRANO will explore whether there is activity of SBRT and SBRT followed by niraparib in the case of oligometastatic or oligoprogression disease post prior PARPi in recurrent ovarian cancer. The trial will recruit patients with oligometastic or oligoprogressive ovarian cancer (≤3 sites/lesions) who have progressed on or following at least 6 months of treatment with PARP Inhibitor (PARPi). Participants may enter one of two parallel non-comparative treatment cohorts: * Cohort 1: SBRT followed by niraparib * Cohort 2: SBRT alone In both cohorts, therapy will continue until disease progression deemed by the investigator to warrant a change in treatment, unacceptable toxicity, withdrawal of consent or if the investigator decides it is not in the best interest of the patient to continue. Adverse events, including toxicity from trial treatment will be collected and graded according to The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 5.0 (http://ctep.cancer.gov/reporting/ctc.html). Participants will be asked to consent for future linkage with routinely collected health data via national registries to trace their eventual vital status and assess subsequent unexpected comorbidities. Assessment of disease by RECIST will be required 8 weekly following completion of SBRT for the first year and 12 weekly thereafter until disease progression meeting the primary endpoint.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ to have been the patient's last systemic therapy
What the study is looking for
- ✓Patients ≥ 18 years of age.
- ✓confirmed by a biopsy epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report...
- ✓Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is...
- ✓Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease.
- ✓≤3 lesions of progressive disease.
Who cannot take part
- ✗Co-morbidities which would preclude the safe use of SBRT.
- ✗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...
See the full criteria
Where Is This Study? (7 UK sites)
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
University College London Hospitals
London NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
How to Get in Touch
Jessica Russell
Sponsor contactCONTACT
Laura Moretti
Sponsor contactCONTACT
