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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (First-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. |
|
| B (Second-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. |
|
| C (Third- or Later-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 25 mg/square metre, D1, D8, D15, repeat every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 60-day Obstruction Clearance Rate | proportion of participants who achieved obstruction clearance within 60 days from start of treatment | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Obstruction Clearance Rate | proportion of participants who achieved obstruction clearance within 30 days from start of treatment | 30 days |
| Time to Obstruction Clearance | interval from start of treatment to obstruction clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Xiao, MD | Contact | 86-20-38250745 | xiao_jian@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Xiao, MD | The Sixth Affiliated Hospital, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated hosipital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17544243 | Background | 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. | |
| 35274188 | Background |
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| Oxaliplatin | Drug | 85 mg/msquare metre, D1, D15, repeat every 4 weeks. |
|
| Fluorouracil | Drug | 1200 mg/square metre, D1, D8, D15, repeat every 4 weeks. |
|
|
| 60 days |
| Obstruction Clearance Duration | interval from obstruction clearance to the next malignant bowel obstruction | 2 years |
| Safety in terms of Adverse Events | according to Common Terminology Criteria for Adverse Events version 5.0 | 2 years |
| Overall Survival | interval from start of treatment to death or last follow-up | 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 | 3 months |
| 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. |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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