Peritoneal Carcinomatosis Clinical Trial
— PERISCOPEIIOfficial title:
Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).
Status | Recruiting |
Enrollment | 182 |
Est. completion date | October 1, 2029 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - 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), considered to be resectable (including lymph nodes) - Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination - Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable - 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: - ANC = 1.5 x 109 /L - Platelet count = 100 x 109 /L - Serum bilirubin = 1.5 x ULN, and ALAT and ASAT = 2.5 x ULN - Creatinine clearance = 50 ml/min (measured or calculated by Cockcroft-Gault formula) - For female patients who are not sterilised or in menopause (i.e., amenorrhea =1 year if age =60 years, or =2 years if age <60 years): - negative pregnancy test (urine/serum) - no breast feeding or active pregnancy ambition - reliable contraceptive methods - Signed informed consent Exclusion Criteria: - Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination - 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 - 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 - Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents |
Country | Name | City | State |
---|---|---|---|
Netherlands | Antoni van Leeuwenhoek/ Netherlands Cancer institute | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen |
Netherlands,
van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | 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. palliative systemic chemotherapy. | 5 years | |
Secondary | progression free survival | To compare the progression free 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. palliative systemic chemotherapy. | 5 years | |
Secondary | treatment-related toxicity | To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC. | 5 years | |
Secondary | costs and health benefits | To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. | 5 years |
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