NIPH Clinical Trials Search

UMIN ID: UMIN000000744

Registered date:21/06/2007

Combination chemotherapy with docetaxel, cisplatine, and 5-fluorouracil for patients with advanced head and neck cancer: a phase I/II trial

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedSquamous cell carcinoma of the head and neck
Date of first enrollment2007/06/01
Target sample size53
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)According to the dose-escalation scheme, docetaxel is administered intravenously at a dose of 50, 60, or 70 mg/m2 on day 1; 70mg/m2 of cisplatin infusion on day 1; continuous 750 mg/m2/d of 5-fluorouracil infusion on days 1 through 5.


Primary OutcomeDetermine the DLT, MTD, and RD in phase I setting. The objective response rate at the RD in phase II setting.
Secondary OutcomeThe proportion of patients who received a second round of TPF chemotherapy on schedule and the proportion of patients completed two cycles of TPF chemotherapy in phase I setting. The overall survival, the progression-free survival, and the adverse events in phase II setting.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Active multiple cancers. (only as for the phase I period) 2) Active infection disease with fever. 3) Serious complications (such as, heart failure, pulmonary fibrosis, interstitial pneumonia, and hemorrhagic tendency). 4) Metastasis to brain. 5) Pleural effusion or ascites requiring continuous drainage. 6) Pericardial effusion requiring treatment. 7) Edema grade 2 or more. 8) Previous history of severe drug hypersensitivity. 9) The patient who is pregnant, lactating, and potentially pregnant or hopes to become pregnant. 10) Long-term use of steroids. 11) The patient who has been judged to be ineligible for participating in this study by the attending physician.

Related Information


public contact
Name Akihito Watanabe
Address Kita1-1, Hondori14-chome, Shiroishi-ku, Sapporo, Japan Japan
Telephone 011-863-2101
Affiliation Keiyukai Sapporo Hospital Department of Otolaryngology
scientific contact
Name Keisuke Masuyama
Address 1110 Shimokato, Chuo-shi, Yamanashi-ken, Japan Japan
Telephone 055-273-6769
Affiliation University of Yamanashi Department of Otorhinolaryngology, Head and Neck Surgery