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New treatment option for Peritoneal Metastases From Gastric Cancer
Official title INTERACT Stomach-II
ClinicalTrials.gov ID: NCT07133490
What this study is testing
What is intraperitoneal chemotherapy?
intraperitoneal chemotherapy is an investigational medicine, being studied as a potential treatment for peritoneal metastases from gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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)...
- Inadequate organ functions (defined as a hemoglobin \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Eindhoven, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Eindhoven, Netherlands; Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.