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/17544243Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID04840264
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
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2024-03-18
79
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination chemotherapy regimen of docetaxel, oxaliplatin, and fluorouracil for adults with gastric or gastroesophageal junction adenocarcinoma who have peritoneal carcinomatosis and inoperable malignant bowel obstruction below the Treitz ligament. This phase II, multi-center, non-randomized trial includes three patient groups based on prior therapy: first-line, second-line, and third- or later-line treatment. The study aims to determine if this regimen can meaningfully clear bowel obstruction in this difficult-to-treat population. The treatment involves intravenous docetaxel given on days 1, 8, and 15; intravenous oxaliplatin on days 1 and 15; and continuous infusion of fluorouracil on days 1, 8, and 15. Each cycle repeats every four weeks. All three groups receive the same experimental regimen, with dosing schedules carefully monitored throughout the study. Participants will receive up to two years of safety and survival follow-up, alongside quality of life assessments. Participants will be closely monitored for bowel obstruction clearance at 30 and 60 days, with additional measures including the duration of obstruction relief, overall survival, adverse events, and quality of life evaluated using a standardized questionnaire. Regular clinical assessments, laboratory tests, and imaging will support safety monitoring. The total participation may last up to two years, allowing researchers to gather comprehensive data on treatment impact and patient well-being.
CONDITIONS
Brief Title
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status of 3 or less
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Peritoneal carcinomatosis confirmed by imaging or pathology
- Malignant bowel obstruction below the Treitz ligament based on clinical or radiological findings
- Considered inoperable malignant bowel obstruction by two independent surgical consultants
- Hemoglobin level of at least 60 g/L, white blood cell count of at least 4 x 10^9/L, absolute neutrophil count of at least 2 x 10^9/L, and platelet count of at least 100 x 10^9/L
- Creatinine level within the upper normal limit
- Total bilirubin, AST, ALT, and ALP levels no higher than 1.5 times the upper normal limit
- Provided written informed consent
You will not qualify if you...
- Prior treatment with a regimen containing all study drugs (docetaxel, oxaliplatin, fluorouracil)
- Allergy to any of the study drugs
- HER-2 amplification or overexpression, mismatch repair protein deletion, or high microsatellite instability
- Strangulated intestinal obstruction
- Active gastrointestinal bleeding
- Uncontrolled active infection
- Severe heart diseases with significant ECG abnormalities or clinical impact
- Severe lung diseases such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- Mental disorders affecting clinical treatment or central nervous system diseases
- Brain or meningeal metastasis
- HIV infection or untreated active hepatitis
- Need for bowel surgery or stenting due to obstruction
- Pregnant or lactating women
- Other conditions deemed unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Repeated 4-week cycles until bowel obstruction clearance or discontinuation
Participants receive a combination chemotherapy regimen of Docetaxel, Oxaliplatin, and Fluorouracil administered in repeated 4-week cycles to treat gastric cancer with inoperable malignant bowel obstruction.
Multiple visits per cycle on Days 1, 8, and 15 for drug administration
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated hosipital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Loading map...
Research Team
J
Jian Xiao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer.
Ainhoa Madariaga, Jenny Lau, Arunangshu Ghoshal...
https://pubmed.ncbi.nlm.nih.gov/35274188