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Looking for participantsPhase2

SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy

Sponsor: Institute of Cancer Research, United Kingdom

NCT ID: NCT05990192

View on ClinicalTrials.gov ↗

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.

Ovarian Cancer Recurrent

How this trial compares with your answers

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What we know so far

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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

CA125by a negative

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
Inclusion Criteria: 1. Patients ≥ 18 years of age. 2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report includes immunohistochemistry confirming ovarian cancer, patient should not be excluded). 3. 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. 4. Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease. 5. ≤3 lesions of progressive disease. 6. Each lesion to undergo SBRT \<4 cm axial diameter, and feasible for SBRT as discussed in the SOPRANO virtual MDT (vMDT) meeting. 7. 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. 8. No contra-indication to restarting a PARP inhibitor. 9. Patients for whom surgery for recurrent disease is not planned. 10. Adequate baseline organ function to allow SBRT to all relevant targets as deemed by the investigator. 11. ECOG performance status of 0 or 1. 12. Predicted life expectancy ≥ 6 months. 13. Women of child-bearing potential who are confirmed NOT to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are: 1. Post-menopausal -- defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, OR women under 50 years old who have been amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and have serum follicle- stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the post-menopausal range for the institution. 2. Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral ovarian failure or bilateral salpingectomy but not tubal ligation. 3. Radiation or chemotherapy-induced oophorectomy or menopause with \> 1 year since last menses. 14. Willingness to commit to scheduled visits, treatments plans, laboratory tests and trial procedures. 15. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available prior to commencing SBRT (specimen can be the sample at diagnosis or taken at relapse or progression). Otherwise, a biopsy must be carried out to obtain sufficient tissue for translational analyses. 16. Able to swallow, absorb and retain oral medication. 17. Able to provide written, informed consent. Exclusion Criteria: 1. Co-morbidities which would preclude the safe use of SBRT. 2. 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. 3. 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. 4. Treatment with any other investigational medicinal product (IMP) within the 4 weeks prior to trial entry. 5. Pregnant or lactating women. 6. Women of childbearing age and potential who are not willing to use a highly effective contraceptive measure. 7. 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. 8. Clinical/radiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry. 9. Any other malignancy which has been active or treated within the past 3 years, with the exception of non-melanoma skin cancer. If prior treatment for another malignancy has taken place, then confirmation of ovarian/fallopian tube/peritoneal cancer progression is required e.g. biopsy, and discussion with the trial Chief Investigator and SBRT Lead 10. Judgment by the Investigator that the patient is unsuitable to participate in the trial and/or the patient is unlikely to comply with trial procedures, restrictions and requirements.

Where Is This Study? (7 UK sites)

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Geoff Hall, ProfessorPrincipal Investigator

Leicester Royal Infirmary

Leicester, United Kingdom

Recruiting
Site contact (verified)
Anu GorePrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Lisa BarracloughPrincipal Investigator

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Charlie GourleyPrincipal Investigator

The Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Susana BanerjeePrincipal Investigator

University College London Hospitals

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Gemma EminowiczPrincipal Investigator

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Susana BanerjeePrincipal Investigator

How to Get in Touch

Jessica Russell

Sponsor contact

CONTACT

+44 2034376516 soprano-icrctsu@icr.ac.uk

Laura Moretti

Sponsor contact

CONTACT

+44 0208 722 4153 soprano-icrctsu@icr.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-07