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A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-Small Cell Lung Cancer (JCOG0403)
This study is ongoing, but not recruiting participants.
First Received: October 13, 2005   Last Updated: February 2, 2009   History of Changes
Sponsors and Collaborators: Japan Clinical Oncology Group
Japanese Ministry of Health, Labor and Welfare
Information provided by: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00238875
  Purpose

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


Condition Intervention Phase
T1N0M0 Non-Small Cell Lung Cancer
 Procedure: stereotactic body radiation therapy
 Phase II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-Small Cell Lung Cancer (JCOG0403)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • 3-years overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • relapse-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • local-relapse free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • 3-years local relapse free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • patterns of relapse [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • acute complications [ Time Frame: within 8 weeks from starting tratment day ] [ Designated as safety issue: Yes ]
  • late complications [ Time Frame: after 8 weeks from starting treatment day ] [ Designated as safety issue: Yes ]
  • serious complication rate [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 167
Study Start Date: July 2004
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Procedure/Surgery: stereotactic body radiation therapy
Procedure: stereotactic body radiation therapy
Procedure/Surgery: 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238875

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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.
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 Sep 15; [Epub ahead of print]

Responsible Party: Japan Clinical Oncology Group ( Masahiro Hiraoka, MD, PhD )
Study ID Numbers: JCOG0403, C000000029
Study First Received: October 13, 2005
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00238875     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
stereotactic body radiation therapy
T1N0M0 non-small cell lung cancer
radiotherapy

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
 Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
 Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009



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