An interventional study of Intervention Group and Control Group in Gastric Cancer, sponsored by National Research Oncology and Transplantology Center, Kazakhstan. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by National Research Oncology and Transplantology Center, Kazakhstan · Not applicable, Interventional, and Prevention
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related mortality. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival rates. Despite these advances, peritoneal carcinomatosis (PC) remains a serious problem, occurring in 60% of cases after radical surgery. PC is associated with poor prognosis and limited treatment options.
Intra-abdominal chemotherapy, particularly hyperthermic intraperitoneal chemoperfusion (HIPEC), has demonstrated advantages in the treatment of PC. However, a new technique, pressurized intraperitoneal aerosolized chemotherapy (PIPAC), is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface as an aerosol, allowing deeper penetration of drugs into tumor implants while minimizing toxicity and invasiveness.
This study hypothesizes that the addition of PIPAC as a preoperative treatment for patients with locally advanced gastric cancer may reduce the incidence of peritoneal carcinomatosis compared to standard therapy. The primary objective of this study is to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in these patients.
Gastric cancer is the fifth most common cancer globally and the third leading cause of cancer-related death. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival outcomes. However, PC remains a major challenge, often occurring in 60% of cases after radical surgery, and is associated with a poor prognosis and limited treatment options.
Intra-abdominal chemotherapy, particularly HIPEC, has shown benefits in the treatment of PC. However, a newer method, PIPAC, is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface via aerosol, ensuring deeper penetration of the drugs into tumor implants and offering lower toxicity and less invasiveness compared to traditional methods.
This study hypothesizes that adding PIPAC as a preoperative treatment in patients with locally advanced gastric cancer may reduce the occurrence of peritoneal carcinomatosis compared to standard therapy alone. PIPAC will be applied before neoadjuvant chemotherapy to patients at high risk for peritoneal recurrence, with the goal of improving survival rates and reducing recurrence after surgery.
The main objectives of this study are to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in patients with locally advanced gastric cancer. Secondary objectives include assessing overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), the occurrence of serious adverse events (SAEs), quality of life (QoL) as measured by the EORTC QLQ-C30, postoperative mortality (Clavien-Dindo classification), and pathological response (TRG) in comparison to patients receiving standard treatment.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 160 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Research Oncology and Transplantology Center, Kazakhstan is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Adults aged 18-70 years with confirmed locally advanced gastric adenocarcinoma (T3-4N0-3M0), performance status 0-2, and negative peritoneal cytology.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
◦ Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Procedure: Intervention Group
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Procedure: Control Group
Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) +gastrectomy with D2 lymphadenectomy
Also known as: doxorubicin (2.1 mg/m2), cisplatin (10 mg/m2), perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomy, Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy
Also known as: standard perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomy
Incidence of peritoneal carcinomatosis
Incidence of Peritoneal Carcinomatosis refers to the frequency or rate at which new cases of peritoneal carcinomatosis are diagnosed within a specific population over a defined period.
Time frame: 12, 24 months after surgery
Overall survival
Overall Survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients are still alive.
Time frame: 1. 3, 5 years after surgery
Disease-free survival
Disease-Free Survival (DFS) is the period of time after treatment during which a patient shows no signs of the disease.
Time frame: 3, 6, 9, 12, 18, 24 months after surgery
Quality of life by EORTC QLQ-C30
Quality of life (assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which is calculated in points)
Time frame: before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Frequency of adverse events
Frequency of Adverse Events (graded by CTCAE v5.0) refers to the rate or proportion of patients experiencing side effects or complications associated with a treatment, categorized according to severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: through study completion, 30 days after surgery, 90 days after surgery
Plan to share: No
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National Research Oncology and Transplantology Center, Kazakhstan