UMIN ID: UMIN000002093
Registered date:20/06/2009
Feasibility study of 5-fluorouracil, leucovorin and paclitaxel (FLTAX) in peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Gastric cancer |
Date of first enrollment | 2009/06/01 |
Target sample size | 20 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 5-FU 500-600mg/m2 days 1, 8, 15 l-Leucovorin 250mg/m2, days 1, 8, 15 Paclitaxel 60-80mg/m2, days 1, 8, 15 Every 28 days |
Outcome(s)
Primary Outcome | Part I: Incidence of dose limiting toxicity Part II: Proportion of patients who completed 2 cycles of the protocol treatment |
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Secondary Outcome | Adverse events, Response rate, Response for ascites, Overall survival, Progression-free survival, Time to treatment failure |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Uncontrollable diabetes mellitus 2. Uncontrollable heart disease 3. Other severe complications such as renal failure, liver failure and intestinal pneumonitis 4. Symptomatic CNS metastasis 5. History of hypersensitivity to alcohol 6. Prior taxane-containing chemotherapy 7. Active bacterial or fungous infection 8. Massive pleural effusion 9. Severe diarrhea 10. Active bleeding 11. Active double cancer 12. Pregnancy, the desire to preserve fecundity, or lactating woman 13. Severe mental disorder 14. Patient evaluated to be inadequate by a attending doctor |
Related Information
Primary Sponsor | National Cancer Center Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | none |
Secondary ID(s) |
Contact
public contact | |
Name | Takako Eguchi Nakajima |
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan |
Telephone | 03-3542-2511 |
taeguchi@ncc.go.jp | |
Affiliation | National Cancer Center Hospital Gastrointestinal Oncology Division |
scientific contact | |
Name | Takako Eguchi Nakajima |
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan |
Telephone | 03-3542-2511 |
Affiliation | National Cancer Center Hospital Gastrointestinal Oncology Division |