Status:
NOT_YET_RECRUITING
INTERACT Stomach-II
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Catharina Ziekenhuis Eindhoven
Netherlands Cancer Institute - NKI
Conditions:
Peritoneal Metastases From Gastric Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 49 pa...
Eligibility Criteria
Inclusion
- Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma
- 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
- Distant metastases other than peritoneal metastases or metastatic lymph nodes
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT07133490
Start Date
October 1 2025
End Date
July 1 2028
Last Update
August 21 2025
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