Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
Recruiting
Phase 3
Interventional Study
Gastric Cancer Peritoneal Metastases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 262 (estimated)
- Sponsor
- Magnus Nilsson · Other
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About This Trial
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 rat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
* Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
* Staging laparoscopy with assessment of peritoneal…
Contacts