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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2011

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.

Interventions

  • Procedure: stereotactic body radiation therapy
    • Procedure/Surgery: stereotactic body radiation therapy

Arms, Groups and Cohorts

  • Experimental: 1
    • Procedure/Surgery: stereotactic body radiation therapy

Clinical Trial Outcome Measures

Primary Measures

  • 3-years overall survival
    • Time Frame: During the study conduct

Secondary Measures

  • 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 treatment day
  • late complications
    • Time Frame: after 8 weeks from starting treatment day
  • serious complication rate
    • Time Frame: During the study conduct

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Haruhiko Fukuda
  • Collaborator
    • Ministry of Health, Labour and Welfare, Japan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Haruhiko Fukuda, JCOG Data Center – Japan Clinical Oncology Group
  • Overall Official(s)
    • Masahiro Hiraoka, MD, PhD, Study Chair, Kyoto Universlty Hospital

References

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.

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