NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedGastric cancer
Date of first enrollment2009/06/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
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 OutcomePart I: Incidence of dose limiting toxicity Part II: Proportion of patients who completed 2 cycles of the protocol treatment
Secondary OutcomeAdverse events, Response rate, Response for ascites, Overall survival, Progression-free survival, Time to treatment failure

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Takako Eguchi Nakajima
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan
Telephone 03-3542-2511
E-mail 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
E-mail
Affiliation National Cancer Center Hospital Gastrointestinal Oncology Division