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

September 21, 2016 updated by: Haruhiko Fukuda
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0403
  • C000000029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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