SOPRANO - Stereotactic radiotherapy alone or stereotactic radiotherapy follow by niraparib treatment for ovarian cancer with progressive disease in three or less lesions, or recurrence of 3 or less metastatic lesions that had previously achieved complete response.
- Conditions
- Oligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinomaCancer
- Registration Number
- ISRCTN13282459
- Lead Sponsor
- Institute of Cancer Research Clinical Trial & Statistics Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 42
1. Patients =18 years of age (Updated 07/11/2023: previously =16 years of age)
2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer
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 virtual 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
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. Note: For Patients randomised to the SBRT followed by the Niraparib Cohort confirm the following prior to Niraparib initiation; Absolute neutrophil count: =1,500/µL, Platelets: =100,000/µL, Hemoglobin: =9 g/dL
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 the start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:
13.1. 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
13.2. Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
13.3. Radiation or chemotherapy-induced oophorectomy or menopause with >1 year since last menses
14. Willingness to commit to scheduled visits, treatment 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
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 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 as detailed in protocol Section 5.5
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival is defined as time from randomisation 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. The primary timepoint of most interest for PFS is at 6 months after randomisation.
- Secondary Outcome Measures
Name Time Method