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.
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.
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.
Parallel
Niraparib oral capsule
DrugNiraparib used following SBRT treatment until disease progression
SBRT
RadiationSBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities.
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.
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).
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).
Overall survival
Overall survival (OS) defined as time from trial entry to death from any cause.
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
Time to widespread metastatic disease
Time to widespread metastatic disease will be measured from the time of trial entry until radiological evidence of widespread metastatic disease, defined as greater than or equal to 4 metastatic sites, regional or distant, or a combination thereof.
Time to second subsequent therapy
Time to second subsequent therapy is defined as time from initiation of first subsequent therapy to commencing second line of therapy (local or systemic) or death (if this occurs before commencement of second subsequent treatment).
Mechanisms of PARP inhibitor resistance, immune-mediated effects, radiosensitivity and toxicities
Measurement of potential mechanisms of PARP inhibitor resistance, immune-mediated effects, radiosensitivity and toxicities. Measured between baseline and 4 weeks post-SBRT, 16, 24 and 48 weeks post trial entry, and disease progression.
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Institute of Cancer Research, United Kingdom
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
