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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521468-36-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Catharina Ziekenhuis Eindhoven | OTHER |
| The Netherlands Cancer Institute | OTHER |
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This is a phase II study conducted in three hospitals in the Netherlands (Erasmus MC in Rotterdam, Catharina Hospital in Eindhoven, and the Netherlands Cancer Institute in Amsterdam). A total of 55 patients will take part. The aim is to test whether a new combination treatment is feasible for patients with gastric peritoneal metastases (PM). The treatment includes chemotherapy (intraperitoneal irinotecan and standard systemic therapy such as CAPOX or FOLFOX), and may also include nivolumab or trastuzumab, depending on biomarker results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal chemotherapy arm | Experimental | Patients in this group will receive intraperitoneal irinotecan in addition to standard systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraperitoneal chemotherapy | Drug | Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intraperitoneal administration of irinotecan | Percentage of patients who completed all planned cycles of intraperitoneal irinotecan in combination with systemic therapy (6 cycles in the case of CAPOX, 8 cycles in the case of FOLFOX) | From enrollment until the completion of all chemotherapy cycles: either 6 cycles of CAPOX (21 days per cycle) or 8 cycles of FOLFOX (14 days per cycle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Micha J de Neijs, Bsc | Contact | 010 70 39640 | m.deneijs@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pieter C van der Sluis, MD PhD | Erasmus MC, University Medical Center Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Catharina Hospital | Recruiting | Eindhoven | Netherlands |
|
| Erasmus MC, University Medical Center Rotterdam | Recruiting | Rotterdam | Netherlands |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006979 |
| Hyperthermia, Induced |