UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019865 |
|---|---|
| Receipt number | R000022947 |
| Scientific Title | A Phase II clinical trial to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2019/03/07 17:41:39 |
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Basic information
Public title
A Phase II clinical trial to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and neck squamous cell carcinoma
Acronym
A Phase II clinical trial of intra-arterial infusion chemotherapy for head and neck SCC
Scientific Title
A Phase II clinical trial to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and neck squamous cell carcinoma
Scientific Title:Acronym
A Phase II clinical trial of intra-arterial infusion chemotherapy for head and neck SCC
Region
| Japan |
Condition
Condition
head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and squamous cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate from starting treatment till 6months after end of treatment
Key secondary outcomes
Response rate
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
We plan intra-arterial administrarion of cisplatinum and docetaxel through the catheter which is put in feeding artery of the cancer.
cisplatinum:40-100mg/m2/weekly
docetaxel:5-15mg/m2/weekly
administration period:3-6weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with head and neck SCC.
2. ECOG PS of 0-2
3. WBC>3000/ul, Platelet>75000/ul, Creatinine<1.5mg/dL, T-Bil<1.5mg/dL, AST/ALT levels 2.5 times the upper limit of normal
4. Patients agreed this study on document of informed consent.
Key exclusion criteria
1. History of intolerance or hypersensitivity to drugs which will be used or any excipient of the product.
2. Current pregnancy
3. Current known active infection
4. Uncontrolled diabetes
5. Severe heart disease
6. Severe pulmonary disease
7. Patients who are judged to be inappropriate for participation in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-222-7171
yokamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Yamasaki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-222-7171
Homepage URL
k.yamasaki@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2015 | Year | 11 | Month | 20 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022947
