Stereotactic radiotherapy alone or followed by niraparib for oligometastases or oligoprogression in ovarian cancer following PARP inhibitor therapy
The Institute of Cancer Research
SOPRANO is a phase II non-comparative clinical trial recruiting 42 patients from approximately 6 UK NHS sites, diagnosed with oligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinoma. Patients will be randomised to receive either stereotactic radiotherapy (SBRT) followed by the PARP Inhibitor (PARPi) Niraparib (cohort 1) or SBRT alone (cohort 2). 21 patients will be allocated to each cohort.
For the purposes of SOPRANO: oligoprogression refers to the situation whereby 3 or less lesions of disease show evidence of progression; oligometastatic disease refers to the situation whereby complete response to treatment has previously been obtained and disease relapse occurs that is limited in number and distribution to 3 or less metastatic/recurrent lesions.
Oligometastases or oligoprogression of ovarian cancer whilst being treated with a PARPi may occur due to a secondary mutation causing resistance to treatment in a small volume of the tumour rather than having total tumour resistance. Eradication of the resistant disease with SBRT would enable continuation of the PARPi treatment to maintain control of the part of the tumour that has retained drug sensitivity and this has the potential to extend the time to disease progression. The primary objective of SOPRANO is to determine whether the use of SBRT with or without Niraparib increases the number of patients without disease progression at 6 months.
In both treatment cohorts, SBRT will be administered in accordance with the UK SABR consortium guidelines for each site of metastases and will consist of between 3 and 8 fractions of radiotherapy spread over 5 to 19 days. Patients in cohort 1 will then receive Niraparib once daily until disease progression (200 or 300mg depending on weight and blood results). All patients will attend follow up visits for clinical and imaging assessments every 8 weeks during the first year, reducing to every 12 weeks thereafter until disease progression.
London - Brighton & Sussex Research Ethics Committee
Date of REC Opinion
27 Oct 2023
Further Information Favourable Opinion