OXALIPLATIN for Gastric cancer with peritoneal carcinomatosis

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- cT3-cT4 tumour (TNM classification, 7th edition(47)), considered to be resectable (including lymph nodes)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion."}
• {"criterion_text":"- Absence of disease progression during systemic chemotherapy (prior to inclusion)"}
• {"criterion_text":"- WHO performance status 0-2"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}

Exclusion criteria

• {"criterion_text":"- Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Uncontrolled diabetes mellitus"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents"}
• {"criterion_text":"- Recurrent gastric cancer"}
• {"criterion_text":"- Prior resection of the primary gastric tumour"}
• {"criterion_text":"- Non-synchronous peritoneal carcinomatosis"}
• {"criterion_text":"- Current other malignancy (other than cervix carcinoma and basalioma)"}
• {"criterion_text":"- Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2"}
• {"criterion_text":"- A known history of hepatitis B or C with active viral replication"}
• {"criterion_text":"- Recent myocardial infarction (< 6 months) or unstable angina"}

Primary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Compare overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC versus those treated with standard palliative systemic chemotherapy."}

Secondary endpoints

• {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":"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."}
• {"endpoint_text":"- Treatment-related toxicity","definition_or_measurement_approach":"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."}
• {"endpoint_text":"- Costs and resource use","definition_or_measurement_approach":"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."}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
• {"endpoint_text":"- Genetic profiles related to tumour response (optional)","definition_or_measurement_approach":"To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional)"}
• {"endpoint_text":"- pharmacokinetics and penetration depth of oxaliplatin and docetaxel (optional)","definition_or_measurement_approach":"To investigate the pharmacokinetics and penetration depth of intra-abdominal oxaliplatin and docetaxel after gastrectomy and cytoreductive surgery. (optional)"}

Sweden

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

21

Number Of Sites

1

Number Of Participants

40

Finland

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

16-01-2025

Processing Time Days

24

Number Of Sites

1

Number Of Participants

40

Denmark

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

30

Number Of Sites

1

Number Of Participants

40

Netherlands

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

21

Number Of Sites

15

Number Of Participants

106

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands