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A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung

A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung - Phase II study on lung DT-SBRT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016547
Enrollment
48
Registered
2015-05-01
Start date
2015-05-01
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

Dynamic tumor tracking radiotherapy using Vero4DRT

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) primary or metastatic lung cancer which satisfies the following conditions: Primary lung cancer (1) (a) pathological or cytological diagnosis of primary lung cancer (b) clinically diagnosed primary lung cancer with a consensus of multiple doctors based on tumor marker, CT, FDG-PET, etc. (2) tumor diameter of 5cm or less and clinical stage of IA-IB diagnosed with imaging studies Metastatic lung cancer (1) clinically diagnosed metastatic lung cancer (2) three or less tumors with diameters of 5cm or less without any extrapulmonary lesions which was diagnosed with imaging studies 2) Ineligibility to standard surgery confirmed by institutional thoracic surgeons, or patient's refusal of surgery 3) Predicted to satisfy dose constraints for the surrounding organ 4) Aged 20 years or more 5) ECOG-PS of 0 to 2 6) Able to keep the patient's position with the arms raised for 30 mins or more 7) Respiratory motion of 10 mm or more

Exclusion criteria

Exclusion criteria: 1) history of radiotherapy to the same area 2) active interstitial pneumonia or pulmonary fibrosis 3) severe diabetes mellitus or collagen disease 4) female who are pregnant or in lactation 5) metal disease which prevents registration of the study 6) other issues which are considered to be inappropriate for the study by the doctors

Design outcomes

Primary

MeasureTime frame
2-year local control rate

Secondary

MeasureTime frame
Overall survival, progression-free survival, local progression-free survival, adverse event, severe adverse event, accuracy in the treatment, dose-volume metrics

Countries

Japan

Contacts

Public ContactYukinori Matsuo

Kyoto University Dept of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine

ymatsuo@kuhp.kyoto-u.ac.jp075-751-3762

Outcome results

None listed

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