Overview

This trial is active, not recruiting.

Condition t1n0m0 non-small cell lung cancer
Treatment stereotactic body radiation therapy
Phase phase 2
Sponsor Japan Clinical Oncology Group
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date July 2004
End date November 2011
Trial size 167 participants
Trial identifier NCT00238875, C000000029, JCOG0403

Summary

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Procedure/Surgery: stereotactic body radiation therapy
stereotactic body radiation therapy
Procedure/Surgery: stereotactic body radiation therapy

Primary Outcomes

Measure
3-years overall survival
time frame: During the study conduct

Secondary Outcomes

Measure
Overall survival
time frame: During the study conduct
relapse-free survival
time frame: During the study conduct
local-relapse free survival
time frame: During the study conduct
3-years local relapse free survival
time frame: During the study conduct
patterns of relapse
time frame: During the study conduct
acute complications
time frame: within 8 weeks from starting tratment day
late complications
time frame: after 8 weeks from starting treatment day
serious complication rate
time frame: During the study conduct

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: 1. Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2. Stage IA with images within 28 days 3. No other intrathoracic lesions 4. Dose constraints of the organs at risk seem to be limited within range 5. Operable (Standard or Limited surgery) or Inoperable 6. Age>=20 7. No previous thoracic radiation 8. No previous chemotherapy 9. ECOG PS=0-2 10. Respiratory function (<=14 days) PaO2>=60 torr FEV1.0>=700 ml 11. Written informed consent Exclusion Criteria: 1. No apparent radiation pneumonitis and fibrosis 2. No active tuberculosis without oral drugs 3. No double cancer 4. No pregnancy 5. No psychiatric disorder 6. No steroid administration

Additional Information

Official title A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-Small Cell Lung Cancer (JCOG0403)
Description To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer,the following questions should be answered. Can SRT be an alternative standard treatment modality for inoperable patients? Can SRT can be a comparable standard treatment modality with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter,and 48 Gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Japan Clinical Oncology Group.