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

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ClinicalTrials.gov Identifier: NCT00238875
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

Study Description
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Brief Summary:
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

Condition or disease Intervention/treatment Phase
T1N0M0 Non-small Cell Lung Cancer Procedure: stereotactic body radiation therapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Study Start Date : July 2004
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Procedure/Surgery: stereotactic body radiation therapy
 Procedure: stereotactic body radiation therapy
Procedure/Surgery: stereotactic body radiation therapy


Outcome Measures
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Primary Outcome Measures :
  1. 3-years overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: During the study conduct ]
  2. relapse-free survival [ Time Frame: During the study conduct ]
  3. local-relapse free survival [ Time Frame: During the study conduct ]
  4. 3-years local relapse free survival [ Time Frame: During the study conduct ]
  5. patterns of relapse [ Time Frame: During the study conduct ]
  6. acute complications [ Time Frame: within 8 weeks from starting treatment day ]
  7. late complications [ Time Frame: after 8 weeks from starting treatment day ]
  8. serious complication rate [ Time Frame: During the study conduct ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238875


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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00238875    
Other Study ID Numbers: JCOG0403
C000000029
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
stereotactic body radiation therapy
T1N0M0 non-small cell lung cancer
radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms