INTERACT Stomach-II
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
intraperitoneal chemotherapy
DrugThrough a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Intraperitoneal chemotherapy armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborator
The Netherlands Cancer Institute
Collaborator
Source ClinicalTrials.gov