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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007996
Receipt No. R000009411
Scientific Title A study on the preventive effect of radiation pneumonitis and the effect on serum biomarker levels with long-term, low-dose macrolide (Clarithromycin) therapy (multicenter randomized comparison).
Date of disclosure of the study information 2012/05/23
Last modified on 2019/03/04

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Basic information
Public title A study on the preventive effect of radiation pneumonitis and the effect on serum biomarker levels with long-term, low-dose macrolide (Clarithromycin) therapy (multicenter randomized comparison).
Acronym A study on the preventive effect of radiation pneumonitis with long-term, low-dose macrolide therapy (YCRG0005).
Scientific Title A study on the preventive effect of radiation pneumonitis and the effect on serum biomarker levels with long-term, low-dose macrolide (Clarithromycin) therapy (multicenter randomized comparison).
Scientific Title:Acronym A study on the preventive effect of radiation pneumonitis with long-term, low-dose macrolide therapy (YCRG0005).
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the preventive effect of long-term, low-dose macrolide therapy (Clarithromycin (CAM)) on the patients with lung cancer under chemoradiotherapy. Furthermore, to clarify the usefullness of serum biomarkers on the prediction of onset, disease severity and prognosis of radiation pneumonitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes disease severity(Grade) of radiation pneumonitis with CTCAEver3.0
Key secondary outcomes Efficacy:
1) Usefluness of various serum biomarker as indicator of disease severity of radiation pneumonitis. The biomarkers including, LDH, CRP, Type III procollagen N-terminal peptide (PIIIP), KL-6, SPD, and SPA, monocyte chemoattractant protein -1 (MCP-1), TGF-beta, IFN-gamma, HO-1, etc.
2) pulmonary function test
3) blood gas analysis
Safety:
adverse events, and their incidence.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The clarithromycin group :
A clarithromycin 200mg tablet is taken once per day for 6 months from immediately after the start of irradiation therapy.
Interventions/Control_2 Without clarithromycin group: without clarithromycin medication.
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. Age : >=20 or <= 75 years old
2. Performance status: 0-1
3. patient with lung cancer(stageII-III) for the purpose of chemoradiotherapy
4. patient by whom consent is got in written form about participation of the study
Key exclusion criteria 1. patient who has merged mltiple organ failure including lungs of four or more internal organs
2.patient with idiopathic pulmonary fibrosis
3. patient who has past of chemotherapy, or chest radiotherapy in the past for other cancer
4. patient with active double cancer
5. patient who take corticosteroids
6. patient with pregnant, breast- feeding, and possibility of pregnancy
7. patient who are considered inappropriate by physicians in charge
8.patient for the purpose of stereotactic radiation therapy
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email shinkai@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
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 横浜市立大学附属市民総合医療センター(神奈川県)
防衛医科大学校病院(埼玉県)
横浜市立大学附属病院(神奈川県)
藤沢市民病院(神奈川県)
大船中央病院(神奈川県)
横浜南共済病院(神奈川県)
関東労災病院(神奈川県)
大和市立病院(神奈川県)
茅ヶ崎市立病院(神奈川県)
横浜栄共済病院(神奈川県)
国立病院横浜医療センター(神奈川県)
済生会横浜市南部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 23 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
2011 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 21 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009411

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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