UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017656 |
|---|---|
| Receipt number | R000020454 |
| Scientific Title | A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer |
| Date of disclosure of the study information | 2015/05/25 |
| Last modified on | 2018/03/31 09:15:48 |
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Basic information
Public title
A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Acronym
A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Scientific Title
A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Scientific Title:Acronym
A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this clinical trial, the maximum tolerrated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy for head and neck cancer
, and the recommended dose (RD) for the prospective study will be determined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
maximum tolerrated dose, recommended dose
Key secondary outcomes
response rate, toxicity, overall survival, local control time, progression free time
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
Combined therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy
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)Head and neck cancer
2)Stage 3, 4A, or 4B
3)Without previous irradiation for head and neck
4)Without previous chemotherapy with cisplatin
5)Squamous cell carcinoma
6)>=20, <=80
7)Performance Status(ECOG) 0-2
8)WBC >3000/mm3, Neutrophil >1500/mm3
9)Hb >9g/dL
10)PLT >=100,000/mm3
11)AST, ALT <3 times the upper limit of normal
12)total bilirubin <2mg/dL
13)Creatinine clearance >50mL/min
14)Provided written informed consent
Key exclusion criteria
1)Prior history of radiotherapy for head and neck
2)History of serious drug allegies
3)With severe complications (hepatic disorder, renal disorder,or heart disease, bowel obstruction, peptic ulcer, severe diabetes)
4)with history of severe mental disorder
5)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
6)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihito Nomoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
nomoto-y@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Toyomasu |
Organization
Mie University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
y-toyomasu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation for research
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020454
