Ignite Creation Date:
2024-05-06 @ 8:44 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02803515
Status:
TERMINATED
Last Update Posted:
2019-09-04
First Post:
2016-06-14
Brief Title:
Hyperthermic Intraperitoneal Chemotherapy HIPEC Predictive Marker and Mechanism
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy HIPEC in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peritoneal carcinomatosis PC is the stage III of the FIGO ovarian cancer staging It corresponds to an advanced stage with a relative 5 year survival rate of 52 The multimodal treatment approach combines neoadjuvant chemotherapy cytoreductive surgery of macroscopic lesions and hyperthermic intraperitoneal chemotherapy HIPEC It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21 The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia 43 However the cellular mechanisms involved are not fully understood but they include cell death pathways and heat shock proteins Hsp70 and Hsp90 RICCI et al showed based on pre-clinical models that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response The aims of this study are to validate these findings in tissue samples of patients with ovarian PC We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response HSPs expression on the cancer cell surface will be determined by flow cytometry Forty-four patients will be included Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity
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