MedTrace Logo

Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis

NCT05541146 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-23

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Intraperitoneal chemotherapy

Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Andre Roncon Dias, MD, PhD · Instituto do Câncer de São Paulo - ICESP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-07-31
Completion
2025-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541146 on ClinicalTrials.gov