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Treatment of peritoneal dissemination in stomach cancer patients with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy; PERISCOPE-2
EU CTIS ID: 2023-510159-53-01
What this study is testing
The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. systemic palliative chemotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Signed informed consent
- Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
- cT3-cT4 tumour (TNM classification, 7th edition(47)), considered to be resectable (including lymph nodes)
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy (paragraph 5.3.1 and 6.2) and proven by pathological examination
- Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion.
You likely can't join if
- Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
- Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
- Recurrent gastric cancer
See the full eligibility criteria
- Age ≥ 18 years
- Signed informed consent
- Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
- cT3-cT4 tumour (TNM classification, 7th edition(47)), considered to be resectable (including lymph nodes)
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy (paragraph 5.3.1 and 6.2) and proven by pathological examination
- Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion.
- Absence of disease progression during systemic chemotherapy (prior to inclusion)
- WHO performance status 0-2
- Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion: o White blood cell count (WBC) >3.0*109/LPlatelet count ≥ 100 x 109 /L o Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN o Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
- For female patients who are not sterilised or in menopause: o negative pregnancy test (urine/serum) o no breast feeding or active pregnancy ambition o reliable contraceptive methods
- Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
- Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
- Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
- A known history of hepatitis B or C with active viral replication
- Recent myocardial infarction (< 6 months) or unstable angina
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.