NCT04840264

Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.

Detailed description

The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.

Conditions

• Metastatic Gastric Adenocarcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DRUG	Docetaxel	25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
DRUG	Oxaliplatin	85 mg/msquare metre, D1, D15, repeat every 4 weeks.
DRUG	Fluorouracil	1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Timeline

• Start date: 2022-01-07
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2021-04-09
• Last updated: 2024-03-18

Locations

1 site across 1 country: China