Stereotactic radiotherapy alone or followed by niraparib for oligometastases or oligoprogression in ovarian cancer following PARP inhibitor therapy

Institute of Cancer Research Clinical Trial & Statistics Unit0 sites42 target enrollmentOctober 30, 2023

ConditionsOligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinoma Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Oligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinoma
Sponsor: Institute of Cancer Research Clinical Trial & Statistics Unit
Enrollment: 42
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 30, 2023

End Date

June 30, 2027

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Institute of Cancer Research Clinical Trial & Statistics Unit

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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