Phase I study of stereotactic body radiation therapy (SBRT) for stage IA, centrally located non-small cell lung cancer

Phase 1

• Conditions: stage IA non-small cell lung cancer

• Registration Number: JPRN-UMIN000004100
• Lead Sponsor: Japanese Radiation Oncology Study Group(JROSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-25
• Study Completion: 2016-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Prior invasive malignancy unless disease free for a minimum of 3 years (e.g., carcinomas in situ, T1N0M0 laryngeal cancer, low risk prostate cancer;T1-2a and Gleason score 2-6 an dPSA < 10 ng/ml, stage I breast, and cancers which can expect long survalval as well as these cancers are permissible) 2)Prior radiotherapy to the region of the study cancer that would result in overlap of radiationtherapy fields; 3) Obvious interstitial pnumonitis or fibrosis on chest X-ray 4) Active infection 5)Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study 6) patients who are judged to be imppsible to participate this study due to psycologic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates ofadverse events other than a dose-limiting toxicity (DLT) which is possibly, or definitely related to treatment and which occurs within 1 year from the start of SBRT.

Secondary Outcome Measures

Name	Time	Method
Rates of treatment completion, incidence of late adverse effects which occurs after 1 year from the start of SBRT, the 3-year local control, recurrence of out pf field, and overall survival rates.