Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504147
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Study of Radspherin in Patients with Primary Advanced Epithelial Cancer with Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomised Open Label Multicentre Study of an Intraperitoneal Α-emitting Radionuclide Therapy Radspherin in Patients with Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer with Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 controlled randomised parallel assignment open label multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer fallopian tube or primary peritoneal cancer with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS The study will be conducted in 2 parts first a Safety Lead-in Cohort will be recruited followed by the randomised part of the study For both parts of the study patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour R0 should be deemed to be achievable during diagnostic work-up Patients in both parts of the study will undergo the same procedures and assessments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None