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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003769
Receipt No. 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

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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
Email

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
Email y-naruo@sc4.so-net.ne.jp

Sponsor
Institute Osaka Lung Cancer Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004564

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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