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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019865
Receipt No. 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

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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
Email 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
Email k.yamasaki@faculty.chiba-u.jp

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022947

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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