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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).

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). - A study on the preventive effect of radiation pneumonitis with long-term, low-dose macrolide therapy (YCRG0005).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007996
Enrollment
72
Registered
2012-05-23
Start date
2012-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

The clarithromycin group : A clarithromycin 200mg tablet is taken once per day for 6 months from immediately after the start of irradiation therapy. Without clarithromycin group: without clarithrom

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
disease severity(Grade) of radiation pneumonitis with CTCAEver3.0

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactMasaharu Shinkai

Yokohama City University Medical Center Respiratory Disease Center

shinkai@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026