Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05644249
Status:
RECRUITING
Last Update Posted:
2023-01-05
First Post:
2022-09-29
Brief Title:
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer
Sponsor:
Vilnius University
Organization:
Vilnius University
Study Overview
Official Title:
Pressurized Intraperitoneal Aerosol Chemotherapy PIPAC and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases Open-label Single-arm Multi-center Feasibility Study
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:
Peritoneum is among the most common sites of metastases in gastric cancer Systemic chemotherapy is the current standard for peritoneal carcinomatosis PC although the treatment results remain extremely poor Pressurized intraperitoneal aerosol chemotherapy PIPAC is a modern treatment modality for PC that 1 optimize the drug distribution by applying an aerosol rather than a liquid solution and 2 apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target Despite some encouraging preliminary results for PIPAC efficacy it is still an investigational treatment Furthermore only very limited data exist for bidirectional treatment which includes a combination of systemic chemotherapy and PIPAC Thus this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases
Detailed Description:
This open-label single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical radiological cytological and histological examination will be considered for enrollment Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 105 mgm2 and doxorubicin 21 mgm2 will be utilized 14 days after each of the systemic chemotherapy cycles After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings In case of downstaging patients will be considered for radical gastrectomycytoreductive surgery others for further systemic therapy All patients will be followed up for 24 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?:
None
Is an FDA AA801 Violation?:
None