Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction.
Thomas Anthony, Todd Baron, Sebastiano Mercadante...
https://pubmed.ncbi.nlm.nih.gov/17544243/Actively Recruiting
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-07-13
79
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating a combination of three chemotherapy drugsdocetaxel, oxaliplatin, and fluorouracilfor treating gastric cancer patients who have peritoneal carcinomatosis and inoperable malignant bowel obstruction. This phase II, multi-center, non-randomized trial includes three groups based on previous treatments first-line, second-line, and third- or later-line therapies. The main goal is to see if this drug regimen can clear bowel obstruction in these patients. Participants receive docetaxel, oxaliplatin, and fluorouracil in repeated 4-week cycles. Docetaxel is given intravenously on days 1, 8, and 15 oxaliplatin on days 1 and 15 and fluorouracil continuously over 24 hours on days 1, 8, and 15. Each of the three groups follows the same drug schedule but differs by prior chemotherapy history. Treatment continues with cycles repeating every 4 weeks. During the study, participants will be monitored for bowel obstruction clearance rates at 30 and 60 days, time to clearance, and how long the clearance lasts up to 2 years. Safety is tracked by recording adverse events over 2 years. Overall survival and quality of life measured by a specific questionnaire are also assessed. Participants will have regular clinical evaluations and laboratory tests throughout the study period, which runs until mid-2028.
CONDITIONS
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
J
Jian Xiao, MD
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Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
Guangdong Provincial People's Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or unacceptable side effects
Participants receive intravenous docetaxel, oxaliplatin, and fluorouracil according to the study schedule in repeated 4-week cycles.
Visits on days 1, 8, and 15 of each 4-week cycle
Duration - Up to 2 years
Participants are monitored for bowel obstruction clearance, overall survival, safety, and quality of life for up to 2 years after treatment.
Regular follow-up visits during 2-year period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Thomas Anthony, Todd Baron, Sebastiano Mercadante...
https://pubmed.ncbi.nlm.nih.gov/17544243/Ainhoa Madariaga, Jenny Lau, Arunangshu Ghoshal...
https://pubmed.ncbi.nlm.nih.gov/35274188/Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
Guangdong Provincial People's Hospital
Collaborating Sponsor