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

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

Study Overview

• Status: Completed
• Conditions: T1N0M0 Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: stereotactic body radiation therapy

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 Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital
  • Hiroshima
    • Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan, 734-8551
      • Hiroshima University, School of Medicine
  • Hokkaido
    • North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
    • S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University
  • Hyogo
    • Kobe,Chuo-ku,Minatojima-Minamimachi,2-2, Hyogo, Japan, 650-0047
      • Institute of Biomedical Research and Innovation Hospital
  • Kanagawa
    • Sagamihara,Kitasato,1-15-1, Kanagawa, Japan, 228-8555
      • Kitasato University School of Medicine
  • Kyoto
    • Kyoto,Sakyoku,Shogoin,Kawahara-cho,54, Kyoto, Japan, 606-8507
      • Kyoto Universlty Hospital
  • Miyagi
    • Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Nara
    • Tenri,Mishima-cho,200, Nara, Japan, 632-8552
      • Tenri Hospital
  • Tokyo
    • Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital
    • Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital
    • Itabashi-ku,Oyaguchikamimachi,30-1, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital
    • Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University
    • Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
      • Keio University Hospital
  • Yamanashi
    • Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan, 409-3898
      • University of Yamanashi Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Procedure/Surgery: stereotactic body radiation therapy	Procedure: stereotactic body radiation therapy; Procedure/Surgery: stereotactic body radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-years overall survival	During the study conduct

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haruhiko Fukuda
• Collaborators: Ministry of Health, Labour and Welfare, Japan
• Investigators: Study Chair: Masahiro Hiraoka, MD, PhD, Kyoto Universlty Hospital

Publications and helpful links

General Publications

• Nagata Y, Negoro Y, Aoki T, Mizowaki T, Takayama K, Kokubo M, Araki N, Mitsumori M, Sasai K, Shibamoto Y, Koga S, Yano S, Hiraoka M. Clinical outcomes of 3D conformal hypofractionated single high-dose radiotherapy for one or two lung tumors using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1041-6. doi: 10.1016/s0360-3016(01)02731-6.
• Nagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19.
• Nagata Y, Hiraoka M, Shibata T, Onishi H, Kokubo M, Karasawa K, Shioyama Y, Onimaru R, Kozuka T, Kunieda E, Saito T, Nakagawa K, Hareyama M, Takai Y, Hayakawa K, Mitsuhashi N, Ishikura S. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Int J Radiat Oncol Biol Phys. 2015 Dec 1;93(5):989-96. doi: 10.1016/j.ijrobp.2015.07.2278. Epub 2015 Nov 11.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 14, 2005

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: radiotherapy; stereotactic body radiation therapy; T1N0M0 non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: JCOG0403; C000000029