UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003769 |
|---|---|
| Receipt number | R000004564 |
| Scientific Title | A phase I study of chemoradiotherapy (cisplatin and vinorelbine) with use of involved-field conformal radiotherapy and accelerated hyperfractionation for stage III non-small cell lung cancer |
| Date of disclosure of the study information | 2010/06/21 |
| Last modified on | 2012/12/17 09:37:52 |
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Basic information
Public title
A phase I study of chemoradiotherapy (cisplatin and vinorelbine)
with use of involved-field conformal radiotherapy
and accelerated hyperfractionation for stage III non-small cell lung cancer
Acronym
A phase I study of chemoradiotherapy with 3DCRT for stage III NSCLC
Scientific Title
A phase I study of chemoradiotherapy (cisplatin and vinorelbine)
with use of involved-field conformal radiotherapy
and accelerated hyperfractionation for stage III non-small cell lung cancer
Scientific Title:Acronym
A phase I study of chemoradiotherapy with 3DCRT for stage III NSCLC
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine a recommended dose of conformal radiotherapy using accelerated hyperfractionation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
recommended dose of radiotherapy
Key secondary outcomes
Toxicity, response, overall survival
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
cisplatin and vinorelbine
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Histologicaly or cytologicaly proven NSCLC
(2) Un-treated patients with IIIA/IIIB NSCLC. When radio-oncologist judged that the patients can tolerable for full dose irradiation.
(3) V20 and less 35%
(4) ECOG Performance status 0-1
(5) age under than 75
(6) Measurable lesion (RECIST)
(7) Adequate organ function
(8) Written informed consent
Key exclusion criteria
(1) With interstitial pneuminia or pulmonary fibrosis
(2) Presence of other active malignancy
(3) Pregnancy or lactating patients
(4) A male without the intention to contraception
(5) With sever cardiac diseases
(6) Un-controlled DM
(7) With sever infection
(8) With high fiver
(9) Previous treatment of thoracic irradiation
(10) Others
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinzoh Kudoh |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruo Yoshimura |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Homepage URL
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Osaka Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪市立大学医学部附属病院 呼吸器内科
KKR大手前病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 17 | Day |
Last modified on
| 2012 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004564
