NCT05977998

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.

Detailed description

Primary Objectives: To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative intraperitoneal paclitaxel and gastrectomy. Secondary Objectives: To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis undergoing treatment with perioperative intraperitoneal paclitaxel.

Conditions

• Gastric Adenocarcinoma
• Carcinomatosis

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given by IP (Intraperitoneal injection)
DRUG	Dexamethasone	Given by IV (vein)
DRUG	Diphenhydramine	Given by IV (vein)
DRUG	Famotidine	Given by IV (vein)

Timeline

• Start date: 2023-09-08
• Primary completion: 2028-10-31
• Completion: 2030-10-31
• First posted: 2023-08-07
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study