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Real-time tumor-tracking proton beam therapy for lung cancer

Phase 1
Conditions
Primary lung cancer
Registration Number
JPRN-UMIN000016575
Lead Sponsor
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
31
Inclusion Criteria

Not provided

Exclusion Criteria

1)With active infections in the irradiated sites 2)With active other cancers 3)With severe uncontrolled diabetes 4)With severe renal failure which needed dialysis 5)With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 6)Previous thoracic irradiation 7)Previous chemotherapy within 12 months before enrollment 8)FEV 1.0 under 700 ml 9)With implantable cardioverter defibrillator or permanent pacemaker 10)Pregnancy 11)Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 12)Cannot be held rest for about 30 minutes 13)Weight over 135 kg 14)Cannot be implanted Au marker in the lung 15)Allergic to radiation 16)Unsuitable for enrollment judged by principal investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of radiation pneumonitis at six months after real-time tumor-tracking proton beam therapy
Secondary Outcome Measures
NameTimeMethod
3-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout and migration of Au markers during treatment period
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