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) studied | Squamous cell carcinoma of the head and neck |
| Date of first enrollment | 2007/06/01 |
| Target sample size | 53 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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. |
Outcome(s)
| Primary Outcome | Determine the DLT, MTD, and RD in phase I setting. The objective response rate at the RD in phase II setting. |
|---|---|
| Secondary Outcome | The 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 minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) 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
| Primary Sponsor | Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Yamanashi |
|---|---|
| Secondary Sponsor | Department of Otolaryngology, Keiyukai Sapporo Hospital |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| 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 |