UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007996 |
|---|---|
| Receipt number | 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 18:02:26 |
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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
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
shinkai@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009411
