Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
49 participants
INTERVENTIONAL
2025-10-01
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraperitoneal chemotherapy arm
Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy
intraperitoneal chemotherapy
Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Interventions
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intraperitoneal chemotherapy
Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Eligibility Criteria
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Inclusion Criteria
* Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)
* WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months
* Aged 18 years or older
* Written informed consent according to the ICH-GCP and national/local regulations
Exclusion Criteria
* Prior palliative systemic therapy for gastric cancer
* Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study
* Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis
* Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
* Any contra-indication for the (planned) systemic chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, persistent neurologic toxicity after (neo-)adjuvant oxaliplatin based systemic therapy), as determined by the treating medical oncologist
* Inadequate organ functions (defined as a hemoglobin \<5.0 mmol/l, an absolute neutrophil count \<1.5 x 109/l, platelet count \<100 x 109/l, creatinine clearance \<30 ml/min, bilirubin \>2x ULN and liver transaminases \>2.5x ULN)
* Pregnant or lactating women
* Concomitant participation in any clinical study that could modify the outcomes relevant to this study
* Absence of assurance of compliance with the protocol
ALL
No
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Netherlands Cancer Institute - NKI
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Pieter Christiaan van der Sluis
Dr.
Principal Investigators
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Pieter C van der Sluis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus MC, University Medical Center Rotterdam
Central Contacts
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Other Identifiers
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2025-521468-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
2025-521468-36-00
Identifier Type: -
Identifier Source: org_study_id
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