BridgeMD
New treatment option for Ovarian Cancer Recurrent
Official title SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
ClinicalTrials.gov ID: NCT05990192
What this study is testing
What is Niraparib oral capsule?
Niraparib oral capsule is an investigational medicine, given as an once-weekly, being studied as a potential treatment for ovarian cancer recurrent.
Also referred to as Zejula.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients ≥ 18 years of age.
- Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report includes immunohistochemistry...
- Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is required to have been the patient's...
- Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease.
- ≤3 lesions of progressive disease.
You likely can't join if
- 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...
- Prior radiotherapy near the oligometastatic / oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- 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...
- Able to swallow, absorb and retain oral medication.
- Able to provide written, informed consent.
- 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...
- 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...
- 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 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leeds, Leeds, United Kingdom
- Leicester, Leicester, United Kingdom
- Manchester, Manchester, United Kingdom
- Edinburgh, Scotland, United Kingdom
- Sutton, Surrey, United Kingdom
- London, UK, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeds, Leeds, United Kingdom; Leicester, Leicester, United Kingdom; Manchester, Manchester, United Kingdom; Edinburgh, Scotland, United Kingdom; Sutton, Surrey, United Kingdom; London, UK, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.