Treatment
This study consists of two different treatment options:
- Arm A: interval debulking + Radspherin
- Arm B: interval debulking
The patient will be randomly allocated to one of the treatment groups on a 2:1 ratio.
Treatment duration
Radspherin is given 2 days after the interval debulking via intraperitoneal in-dwelling catheter placed during surgery.
Eligibility
Main inclusion criteria:
- Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV)
- Peritoneal and other metastases eligible for IDS to no residual tumour
- Confirmed HRD proficient by Myriad MyChoice CDx testing
- Completed 3 or 4 cycles of NACT with regress or stable disease on diagnostic imaging and assessed to be operable to R0
Main exclusion criteria:
- Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HRD deficient.
- Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images
- Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer
- Disease progression during 3 to 4 cycles of NACT
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06504147). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be