Peritoneal Carcinomatosis Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 79 |
Est. completion date | June 30, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 18-75 years of age; - ECOG PS =3; - pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma; - peritoneal carcinomatosis established by imaging data or pathological evidence; - MBO below the Treitz ligament based on clinical grounds or radiological findings; - considered as inoperable MBO by two independent surgical consultants; - Hb=60g/L, WBC =4×10E9/L, ANC=2×10E9/L,PLT=100×10E9/L; - Cr= Upper Normal Limit(UNL); - Tbil=1.5 UNL,AST=1.5 UNL, ALT=1.5 UNL, ALP=1.5 UNL; - Written informed consent form paticipants. Exclusion Criteria: - treated by a combination regimen containing all the study drugs; - allergy to any of the study drugs; - HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H); - strangulated intestinal obstruction; - active gastrointestinal bleeding; - uncontrolled active infection; - unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina); - severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc); - mental disorders that affect clinical treatment or central nervous system diseases; - concomitant cerebral parenchymal or meningeal metastasis; - HIV infection or untreated active hepatitis; - bowel surgery or stenting required due to obstruction; - pregnant or lactating women; - other conditions that are not suitable for participation in the study. |
Country | Name | City | State |
---|---|---|---|
China | The Sixth Affiliated hosipital, Sun Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sixth Affiliated Hospital, Sun Yat-sen University |
China,
Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. — View Citation
Madariaga A, Lau J, Ghoshal A, Dzierzanowski T, Larkin P, Sobocki J, Dickman A, Furness K, Fazelzad R, Crawford GB, Lheureux S. MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer. Support Care Cancer. 2022 Jun;30(6):4711-4728. doi: 10.1007/s00520-022-06889-8. Epub 2022 Mar 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 60-day Obstruction Clearance Rate | proportion of participants who achieved obstruction clearance within 60 days from start of treatment | 60 days | |
Secondary | 30-day Obstruction Clearance Rate | proportion of participants who achieved obstruction clearance within 30 days from start of treatment | 30 days | |
Secondary | Time to Obstruction Clearance | interval from start of treatment to obstruction clearance | 60 days | |
Secondary | Obstruction Clearance Duration | interval from obstruction clearance to the next malignant bowel obstruction | 2 years | |
Secondary | Safety in terms of Adverse Events | according to Common Terminology Criteria for Adverse Events version 5.0 | 2 years | |
Secondary | Overall Survival | interval from start of treatment to death or last follow-up | 2 years | |
Secondary | Quality of Life assessed by EORTC QLQ-OG25 | in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25 | 3 months |
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