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Recruitment status
Unique ID issued by UMIN UMIN000000744
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Yamanashi
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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