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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
The Sixth Affiliated hosipital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITING60-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
Time frame: 60 days
30-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Time frame: 30 days
Time to Obstruction Clearance
interval from start of treatment to obstruction clearance
Time frame: 60 days
Obstruction Clearance Duration
interval from obstruction clearance to the next malignant bowel obstruction
Time frame: 2 years
Safety in terms of Adverse Events
according to Common Terminology Criteria for Adverse Events version 5.0
Time frame: 2 years
Overall Survival
interval from start of treatment to death or last follow-up
Time frame: 2 years
Quality of Life assessed by EORTC QLQ-OG25
in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25
Time frame: 3 months
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