Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
Condition(s) studied
Investigational drug(s) / intervention(s)
Intraperitoneal Paclitaxel: Intraperitoneally administered Paclitaxel
Standard systemic therapy: Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
Study summary
The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
Eligibility
Primary outcome measure(s)
- Overall survival (OS) — Assessed every second month from randomization until study completion, during a maximum of 60 months.
Overall survival (OS), defined as time from randomisation to death from any cause. For subjects who are still alive at the End of Study (EoS), or who are lost to follow up, OS time will be censored at the last recorded date that the subject was known to be alive.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Not Yet Recruiting |
| Amsterdam University Medical Center | Amsterdam | Netherlands | Not Yet Recruiting |
| Sahlgrenska University Hospital | Gothenburg | Sweden | Not Yet Recruiting |
| Skane University Hospital | Lund | Sweden | Not Yet Recruiting |
| Örebro University Hospital | Örebro | Sweden | Not Yet Recruiting |
| Karolinska University Hospital | Stockholm | Sweden | Recruiting |
| Uppsala University Hospital | Uppsala | Sweden | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07304271 on ClinicalTrials.gov ↗ ← All trials in Italy