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Status:

COMPLETED

A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)

Lead Sponsor:

Haruhiko Fukuda

Collaborating Sponsors:

Ministry of Health, Labour and Welfare, Japan

Conditions:

T1N0M0 Non-small Cell Lung Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE2

Brief Summary

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

Detailed 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 patie...

Eligibility Criteria

Inclusion

  • Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
  • Stage IA with images within 28 days
  • No other intrathoracic lesions
  • Dose constraints of the organs at risk seem to be limited within range
  • Operable (Standard or Limited surgery) or Inoperable
  • Age\>=20
  • No previous thoracic radiation
  • No previous chemotherapy
  • ECOG PS=0-2
  • Respiratory function (\<=14 days) PaO2\>=60 torr FEV1.0\>=700 ml
  • Written informed consent

Exclusion

  • No apparent radiation pneumonitis and fibrosis
  • No active tuberculosis without oral drugs
  • No double cancer
  • No pregnancy
  • No psychiatric disorder
  • No steroid administration

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2011

Estimated Enrollment :

167 Patients enrolled

Trial Details

Trial ID

NCT00238875

Start Date

July 1 2004

End Date

November 1 2011

Last Update

September 22 2016

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

Kyushu University Hospital

Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582

2

Hiroshima University, School of Medicine

Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan, 734-8551

3

Hokkaido University Hospital

North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648

4

Sapporo Medical University

S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543