UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007001 |
|---|---|
| Receipt number | R000008262 |
| Scientific Title | Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancers |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2012/07/02 20:06:01 |
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Basic information
Public title
Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancers
Acronym
Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancers
Scientific Title
Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancers
Scientific Title:Acronym
Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancers
Region
| Japan |
Condition
Condition
Laryngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate safety, tolerability and response of alternating chemoradiotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate
Laryngeal preservation rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rapid alternating chemoradiotherapy
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)Previously untreated and stage III/IV squamous cell carcinoma of larynxs are the candidates for our study.
2)PS 0-1
3) Adequate organ functions
Key exclusion criteria
1)Previously treated patients
2)A history of radiation therapy
3)Serious complication
4)A history of cerebral infarction
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Hasegawa |
Organization
Aichi Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
Address
1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aichi Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
Address
TEL
052-762-6111
Homepage URL
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 01 | Month | 01 | 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
| 2006 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 01 | Day |
Last modified on
| 2012 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
