Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis

Gastric Cancer Clinical Trial

Official title:

Evaluation of Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer in Patients With Peritoneal Carcinomatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541146
• Other study ID #: NP 1507/19
• Secondary ID: 26306419.8.0000.
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: September 2022
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Andre Roncon Dias, MD, PhD
• Phone: +55 11 3893-2000
• Email: andre.dias[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective study lasting 36 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Gastric adenocarcinoma

• Presence of peritoneal carcinomatosis documented through intraoperative identification and confirmed by biopsies and/or positive oncotic cytology;

• Presence of exclusively peritoneal metastasis with PCI < 12;

• Age between 18 and 75 years;

• Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1;

• Body mass index (BMI) greater than 18;

• Total WBC count =3000, neutrophils =1500, hemoglobin =8, and platelet count =100,000;

• Bilirubin <2, TGO/TGP/FA/GGT 3x the reference value;

• Creatinine clearance calculated by the Cockcroft-Gault formula = 50 ml/min.

Exclusion Criteria:

• Synchronous or metachronic neoplasms;

• Previous antineoplastic treatment for gastric cancer;

• Clinical conditions considered critical by the investigator;

• Obstruction of the digestive tract;

• Suspected gastrointestinal bleeding;

• New York Heart Association functional class II/III/IV heart failure;

• Heart disease that, in the opinion of the investigator, prevents the patient from receiving the necessary hydration during chemotherapy with cisplatin.

• Known HIV infection or chronic use of immunosuppressants;

• Acute myocardial infarction or stroke in the last 6 months

• pregnant.

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Câncer de São Paulo - ICESP	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete peritoneal response after 04 cycles of intraperitoneal (IP) chemotherapy (CMT) associated with systemic CMT with XP.	Absence of visible carcinomatosis on imaging tests, absence of viable peritoneal lesion at laparoscopy and absence of neoplastic cells in peritoneal lavage.	At the end of Cycle 4 (each cycle is 8 days)
Secondary	Progression-free survival (PFS)	Time between conversion surgery and date of disease progression, assessed in the first 6 months	6 months
Secondary	Overall survival (OS)	Time between conversion surgery and last follow-up after 5 years	5 years