Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05541146
Status:
RECRUITING
Last Update Posted:
2023-03-23
First Post:
2022-08-23
Brief Title:
Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Instituto do Cancer do Estado de São Paulo
Study Overview
Official Title:
Evaluation of Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer in Patients With Peritoneal Carcinomatosis
Status:
RECRUITING
Status Verified Date:
2022-09
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 in gastric cancer GC is considered a fatal disease without expectation of definitive cure Since conventional surgery is not indicated in the palliative setting and systemic chemotherapy treatments are not sufficient to contain the disease a multimodal approach associating intraperitoneal IP chemotherapy CMT with surgery may represent an alternative for these patients
IP CMT has shown superior results to conventional treatment in patients at this stage of the disease and can achieve complete regression of lesions in a significant portion of cases Once response to treatment is achieved patients become fit for curative surgery which offers a new perspective on the survival in these previously unresectable cases and raising survival rates to similar levels to patients undergoing surgery with curative intention
Thus the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo ICESP treated with IP CMT Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions Those with complete regression may be referred for surgical treatment curing a portion of these patients The diagnosis of PC will be performed by conventional cytological immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods In addition it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment
It is believed that IP CMT may not only increase the survival of patients with PC but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months
IP CMT has shown superior results to conventional treatment in patients at this stage of the disease and can achieve complete regression of lesions in a significant portion of cases Once response to treatment is achieved patients become fit for curative surgery which offers a new perspective on the survival in these previously unresectable cases and raising survival rates to similar levels to patients undergoing surgery with curative intention
Thus the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo ICESP treated with IP CMT Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions Those with complete regression may be referred for surgical treatment curing a portion of these patients The diagnosis of PC will be performed by conventional cytological immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods In addition it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment
It is believed that IP CMT may not only increase the survival of patients with PC but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months
Detailed Description:
This is a prospective study lasting 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 26306419800000065 | REGISTRY | None | None |
| 202013249-0 | OTHER_GRANT | The Sao Paulo Research Foundation FAPESP | None |