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Trial Title:
Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis
NCT ID:
NCT05541146
Condition:
Gastric Cancer
Peritoneal Carcinomatosis
Conditions: Official terms:
Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Paclitaxel
Conditions: Keywords:
Gastric Cancer
intraperitoneal chemotherapy
gastric adenocarcinoma
conversion surgery
stage IV gastric cancer
peritoneal metastases
carcinomatosis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Intraperitoneal chemotherapy
Description:
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
Arm group label:
Intraperitoneal chemotherapy
Other name:
Implantation of intraperitoneal catheter for chemotherapy with Paclitaxel
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.
Detailed description:
This is a prospective study lasting 36 months.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Câncer de São Paulo - ICESP
Address:
City:
São Paulo
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Andre Roncon Dias, MD, PhD
Email:
andre.dias@hc.fm.usp.br
Investigator:
Last name:
Andre Roncon Dias, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Ulysses Ribeiro Jr, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marcus Fernando Kodama Pertille Ramos, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Amir Zeide Charruf, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marina Alessandra Pereira, MSc
Email:
Sub-Investigator
Start date:
June 1, 2022
Completion date:
January 2025
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541146
