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

Phase 2
Completed
Conditions
T1N0M0 Non-small Cell Lung Cancer
Interventions
Procedure: stereotactic body radiation therapy
Registration Number
NCT00238875
Lead Sponsor
Haruhiko Fukuda
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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
167
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1stereotactic body radiation therapyProcedure/Surgery: stereotactic body radiation therapy
Primary Outcome Measures
NameTimeMethod
3-years overall survivalDuring the study conduct
Secondary Outcome Measures
NameTimeMethod
relapse-free survivalDuring the study conduct
local-relapse free survivalDuring the study conduct
serious complication rateDuring the study conduct
Overall survivalDuring the study conduct
acute complicationswithin 8 weeks from starting treatment day
late complicationsafter 8 weeks from starting treatment day
patterns of relapseDuring the study conduct
3-years local relapse free survivalDuring the study conduct

Trial Locations

Locations (16)

Kyushu University Hospital

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

Hiroshima University, School of Medicine

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

Hokkaido University Hospital

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

Sapporo Medical University

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

Institute of Biomedical Research and Innovation Hospital

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Kobe,Chuo-ku,Minatojima-Minamimachi,2-2, Hyogo, Japan

Kitasato University School of Medicine

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Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Kyoto Universlty Hospital

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Kyoto,Sakyoku,Shogoin,Kawahara-cho,54, Kyoto, Japan

Tohoku University Hospital

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Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Tenri Hospital

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Tenri,Mishima-cho,200, Nara, Japan

The University of Tokyo Hospital

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Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan

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Kyushu University Hospital
🇯🇵Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
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