Peritoneal Metastases From Gastric Cancer
Conditions
Keywords
Gastric cancer, Peritoneal metastases, Intraperitoneal chemotherapy, Irinotecan
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 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.
Interventions
Through a peritoneal access port, irinotecan will be administered at the same time as systemic (chemo)therapy
Sponsors
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intraperitoneal administration of irinotecan | 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) | 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) |
Countries
Netherlands
Contacts
CONTACTMicha J de Neijs, Bsc
PRINCIPAL_INVESTIGATORPieter C van der Sluis, MD PhD
Erasmus MC, University Medical Center Rotterdam
Outcome results
None listed