UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000744 |
|---|---|
| Receipt number | R000000893 |
| Scientific Title | Combination chemotherapy with docetaxel, cisplatine, and 5-fluorouracil for patients with advanced head and neck cancer: a phase I/II trial |
| Date of disclosure of the study information | 2007/06/21 |
| Last modified on | 2007/06/21 16:19:16 |
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Basic information
Public title
Combination chemotherapy with docetaxel, cisplatine, and 5-fluorouracil for patients with advanced head and neck cancer: a phase I/II trial
Acronym
TPF chemotherapy for advanced head and neck cancer: a phase I/II trial
Scientific Title
Combination chemotherapy with docetaxel, cisplatine, and 5-fluorouracil for patients with advanced head and neck cancer: a phase I/II trial
Scientific Title:Acronym
TPF chemotherapy for advanced head and neck cancer: a phase I/II trial
Region
| Japan |
Condition
Condition
Squamous cell carcinoma of the head and neck
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the dose limiting toxicity (DLT), maximum-tolerated dose (MTD) and recommended dose (RD) of the combination chemotherapy regimen of docetaxel, cisplatine and 5-fluorouracil for stage III or IV squamous cell carcinoma of the head and neck and to evaluate the safety and efficacy of the regimen at the RD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Determine the DLT, MTD, and RD in phase I setting.
The objective response rate at the RD in phase II setting.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed head and neck squamous cell carcinoma.
2) Stage III or IV disease.
3) Measurable disease according to RECIST criteria.
4) ECOG Performance Status 0 to 1.
5) No prior treatment for head and neck cancer.
6) No prior chemotherapy for any malignant disease.
7) Oral intake is possible.
8) Life expectancy >= 3 months.
9) The patient's laboratory data 14 days before starting chemotherapy is as follows: Hemoglobin >= 9.0 g/dl, WBC >= 4000 /mm3, WBC <= 12000 /mm3, Neutrophil >= 2000 /mm3, Platelets >= 100000 /mm3, T-Bil <= 1.5 mg/dl, GOT <= 2.5 times upper limit of normal (ULN), GPT <= 2.5 times upper limit of normal (ULN), Ccr >= 60 ml/min/body, and SpO2 (Room air) >= 95%.
10) The patient who have given written informed consent to participant in this study.
Key exclusion 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.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Masuyama |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi-ken, Japan
TEL
055-273-6769
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Watanabe |
Organization
Keiyukai Sapporo Hospital
Division name
Department of Otolaryngology
Zip code
Address
Kita1-1, Hondori14-chome, Shiroishi-ku, Sapporo, Japan
TEL
011-863-2101
Homepage URL
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Otolaryngology, Keiyukai Sapporo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2007 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 20 | Day |
Last modified on
| 2007 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000893
