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).
Phase 2
- Conditions
- ung cancer
- Registration Number
- JPRN-UMIN000007996
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease severity(Grade) of radiation pneumonitis with CTCAEver3.0
- Secondary Outcome Measures
Name Time Method 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.