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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-14
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

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

Group	Intervention	Description
1	stereotactic body radiation therapy	Procedure/Surgery: stereotactic body radiation therapy

Primary Outcome Measures

Name	Time	Method
3-years overall survival	During the study conduct

Secondary Outcome Measures

Name	Time	Method
relapse-free survival	During the study conduct
local-relapse free survival	During the study conduct
serious complication rate	During the study conduct
Overall survival	During the study conduct
acute complications	within 8 weeks from starting treatment day
late complications	after 8 weeks from starting treatment day
patterns of relapse	During the study conduct
3-years local relapse free survival	During the study conduct

Trial Locations

Locations (16)

The University of Tokyo Hospital; 🇯🇵 Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan

Tohoku University Hospital; 🇯🇵 Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Institute of Biomedical Research and Innovation Hospital; 🇯🇵 Kobe,Chuo-ku,Minatojima-Minamimachi,2-2, Hyogo, Japan

Kitasato University School of Medicine; 🇯🇵 Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Sapporo Medical University; 🇯🇵 S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan

Nihon University Itabashi Hospital; 🇯🇵 Itabashi-ku,Oyaguchikamimachi,30-1, Tokyo, Japan

Tokyo Women's Medical University; 🇯🇵 Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan

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

Hiroshima University, School of Medicine; 🇯🇵 Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan

Hokkaido University Hospital; 🇯🇵 North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan

Kyoto Universlty Hospital; 🇯🇵 Kyoto,Sakyoku,Shogoin,Kawahara-cho,54, Kyoto, Japan

Tenri Hospital; 🇯🇵 Tenri,Mishima-cho,200, Nara, Japan

Keio University Hospital; 🇯🇵 Shinjuku-ku,Shinanomachi,35, Tokyo, Japan

Tokyo Metropolitan Komagome Hospital; 🇯🇵 Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan

Cancer Institute Hospital; 🇯🇵 Koto-ku,Ariake,3-10-6, Tokyo, Japan

University of Yamanashi Faculty of Medicine; 🇯🇵 Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan