Ovarian Cancer RecurrentPhase 2SOPRANONCT05990192
SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
A Phase 2 study testing Niraparib oral capsule and SBRT in people with Ovarian Cancer Recurrent, run by Institute of Cancer Research, United Kingdom at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- Niraparib oral capsule and SBRT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 20 Jun 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Patients for whom surgery for recurrent disease is not planned.
- Adequate baseline organ function to allow SBRT to all relevant targets as deemed by the investigator.
- ECOG performance status of 0 or 1.
- Predicted life expectancy ≥ 6 months.
- 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:
- 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.
- Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral ovarian failure or bilateral salpingectomy but not tubal ligation.
- Radiation or chemotherapy-induced oophorectomy or menopause with > 1 year since last menses.
- Willingness to commit to scheduled visits, treatments plans, laboratory tests and trial procedures.
- 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.
- Able to swallow, absorb and retain oral medication.
- Able to provide written, informed consent.
Who cannot join
- 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.
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- 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.
- 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
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites, 7 recruiting
- Recruiting
Western General Hospital
Edinburgh, Scotland, EH4 2XU
Hannah McKinlay, 0131 537 2444, hannah.mckinlay@nhs.scot
Charlie Gourley
- Recruiting
St James's University Hospital
Leeds, Leeds, LS9 7TF
Amy Burkinshaw, 01132068603, leedsth-tr.oncologydatamanagement@nhs.net
Geoff Hall, Professor
- Recruiting
Leicester Royal Infirmary
Leicester, Leicester
Donna Ward, 0116 258 6972, donna.ward35@nhs.net
Anu Gore
- Recruiting
University College London Hospitals
London, UK, NW1 2PG
Janani Vijeyakumar, 00 44 203 447 7832, janani.vijeyakumar@nhs.net
Gemma Eminowicz
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Kylie Fitch, Kylie.Fitch@rmh.nhs.uk
Susana Banerjee
- Recruiting
The Christie NHS Foundation Trust
Manchester, Manchester, M20 4BX
Jonathan Archer, jonathan.archer1@nhs.net
Lisa Barraclough
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Kylie Fitch, Kylie.fitch@rmh.nhs.uk
Susana Banerjee
About this study
Official title: SOPRANO: Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- Niraparib oral capsule, SBRT
- Keywords
- Ovarian Cancer, Oligoprogressive, Oligometastatic, SBRT, PARP Inhibitor
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib oral capsuleDrug
Also called Zejula
Niraparib used following SBRT treatment until disease progression
SBRTRadiation
Also called Stereotactic Body Radiotherapy
SBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities.
| Study group | Role | What they receive |
|---|---|---|
| SBRT followed by Niraparib | Other | SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated.
Niraparib treatment will start 4 weeks post completion of SBRT treatment and will continue daily until disease progression or other discontinuation criteria are met. Niraparib comes in oral tablet form and the starting dose will be 200mg per day (once a day) or 300mg per day (once a day) calculated by participant's weight and platelet count. Receives: Drug: Niraparib oral capsule; Radiation: SBRT |
| SBRT alone | Other | SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival is defined as time from trial entry to evidence of progression of cancer at any site or death from any cause. Progression events should be imaging defined in all tumour types according to RECIST v1.1 criteria. Where SBRT specific consensus response assessment criteria exist for specific sites (e.g. spine), progression of SBRT treated lesions will be defined according to these guidelines.
Measured: The primary timepoint of most interest for PFS is at six months after trial entry
Secondary outcomes (10)
Time to first subsequent systemic therapy
Time to first subsequent systemic therapy is defined as time from trial entry to commencing next systemic line of therapy or death from any cause (if this occurs before commencement of first subsequent treatment).
Measured: Time to first subsequent systemic therapy assessed up to 2 years after trial entry.
Time to first subsequent anti-cancer therapy
Time to first subsequent anti-cancer therapy is defined as time from trial entry to commencing next line of therapy (local or systemic) or death from any cause (if this occurs before commencement of first subsequent treatment).
Measured: Time to first subsequent anti-cancer therapy assessed up to 2 years after trial entry.
Overall survival
Overall survival (OS) defined as time from trial entry to death from any cause.
Measured: The primary timepoint of interest for OS is at two years after trial entry.
Local control at site of SBRT
Local control at site of SBRT is defined as time from trial entry until radiological evidence of progression at the treated site and be measured on a lesion based analysis using RECIST v1.1 criteria
Measured: Local control at site of SBRT assessed up to 2 years after trial entry.
Time to 'Out of SBRT field' progression
Time to 'Out of SBRT field' progression is defined as time from trial entry until radiological evidence of progression outside of treated area(s) for SBRT treatment using RECIST v1.1.
Measured: Time to 'Out of SBRT field' progression assessed up to 2 years after trial entry.
Clinician reported acute and late toxicity
Clinician reported acute and late toxicity will be graded using NCI CTCAE v5.0. Adverse events will be collected from start of treatment to disease progression (and 30 days post last dose of Niraparib for patients in cohort 1.
Measured: Acute events are defined as those occurring up to 3 months follow up; late events are reported from 6 months post trial entry.
Quality of Life Assessments - FACT-O
Functional Assessment of Cancer Therapy - Ovarian (FACT-O): FACT-O is a self-report measure that assesses physical well-being, social/family well-being, emotional well-being, functional well-being and ovarian cancer-specific subscale. The higher the score, the better the QOL.
Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression. Changes from baseline at each time point will be compared within groups as well as between treatment cohorts.
Measured: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Quality of Life Assessments - EQ5D
EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The higher the score, the better the QOL.
Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression. Changes from baseline at each time point will be compared within groups as well as between treatment cohorts.
Measured: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Feasibility of recruitment rate for the trial
Feasibility of recruitment is defined as the recruitment rate for the trial
Measured: Recruitment is expected to be over 2.5 years
Proportion of patients receiving SBRT in the absence of new developing widespread disease
Proportion of patients receiving SBRT in the absence of new developing widespread disease, defined as greater than or equal to 4 metastatic sites, regional or distant, or a combination thereof.
Measured: Proportion of patients receiving SBRT in the absence of new developing widespread disease assessed up to 2 years after trial entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Susana Banerjee, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990192
- Sponsor's protocol ID
- ICR-CTSU/2022/10082
- Other IDs
- 2022-003175-42, CCR5726, 23/LO/0719
- Acronym
- SOPRANO
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOPRANO: Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT05990192
- Acronym / sponsor ID
- SOPRANO / ICR-CTSU/2022/10082
- Conditions
- Ovarian Cancer Recurrent
- Keywords
- Ovarian Cancer, Oligoprogressive, Oligometastatic, SBRT, PARP Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT followed by Niraparib | Other | Drug: Niraparib oral capsule, Radiation: SBRTSBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. Niraparib treatment will start 4 weeks post completion of SBRT treatment and will continue daily until disease progression or other discontinuation criteria are met. Niraparib comes in oral tablet form and the starting dose will be 200mg per day (once a day) or 300mg per day (once a day) calculated by participant's weight and platelet count. |
| SBRT alone | Other | Radiation: SBRTSBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib oral capsuleAlso: ZejulaNiraparib used following SBRT treatment until disease progression | Drug | SBRT followed by Niraparib |
| SBRTAlso: Stereotactic Body RadiotherapySBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities. | Radiation | SBRT alone, SBRT followed by Niraparib |
Primary outcome
Progression free survival
Time frame: The primary timepoint of most interest for PFS is at six months after trial entry
Progression free survival is defined as time from trial entry to evidence of progression of cancer at any site or death from any cause. Progression events should be imaging defined in all tumour types according to RECIST v1.1 criteria. Where SBRT specific consensus response assessment criteria exist for specific sites (e.g. spine), progression of SBRT treated lesions will be defined according to these guidelines.
10 secondary outcomes
Time to first subsequent systemic therapy
Time frame: Time to first subsequent systemic therapy assessed up to 2 years after trial entry.
Time to first subsequent anti-cancer therapy
Time frame: Time to first subsequent anti-cancer therapy assessed up to 2 years after trial entry.
Overall survival
Time frame: The primary timepoint of interest for OS is at two years after trial entry.
Local control at site of SBRT
Time frame: Local control at site of SBRT assessed up to 2 years after trial entry.
Time to 'Out of SBRT field' progression
Time frame: Time to 'Out of SBRT field' progression assessed up to 2 years after trial entry.
Clinician reported acute and late toxicity
Time frame: Acute events are defined as those occurring up to 3 months follow up; late events are reported from 6 months post trial entry.
Quality of Life Assessments - FACT-O
Time frame: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Quality of Life Assessments - EQ5D
Time frame: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Feasibility of recruitment rate for the trial
Time frame: Recruitment is expected to be over 2.5 years
Proportion of patients receiving SBRT in the absence of new developing widespread disease
Time frame: Proportion of patients receiving SBRT in the absence of new developing widespread disease assessed up to 2 years after trial entry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Banerjee principal investigator
Royal Marsden NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib oral capsule and SBRT in people with Ovarian Cancer Recurrent, run by Institute of Cancer Research, United Kingdom at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Russell (+44 2034376516, soprano-icrctsu@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: The primary timepoint of most interest for PFS is at six months after trial entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.