Docetaxel, Oxaliplatin and 5-FU in Metastatic Gastric Adenocarcinoma With Inoperable Malignant Bowel Obstruction

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of docetaxel, oxaliplatin and 5-Fluorouracil for advanced gastric or gastroesophageal junction adenocarcinoma with inoperable malignant bowel obstruction: the triplet regimen will be given as 1st, 2nd or 3rd line treatment to participants. The primary study hypothesis is that the regimen will provide a clinically meaningful Bowel Obstruction Remission.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Docetaxel; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• Age ≥ 18 years of age;

• Diagnosis of bowel obstruction secondary to gastric or Gastroesophageal Junction adenocarcinoma caused either by tumor itself or adhesions in the setting of active malignancy;

• Cross-sectional imaging performed within 7 days of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain);

• Patient must be considered as inoperable MBO by a surgical consultant;

• Written informed consent form patients;

Exclusion Criteria:

• Bacteremia/septicemia with a documented positive blood culture;

• Patients already received the same regimen prior to study enrollment;

• Patients undergoing bowel surgery or stent placement for the obstruction;

• Those patients complicated with incarcerated hernia;

• Pregnant or nursing female participants.