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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Japan Clinical Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00238875
First received: October 13, 2005
Last updated: February 2, 2009
Last verified: February 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238875

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

Additional Information:
Publications:
Responsible Party: Masahiro Hiraoka, MD, PhD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00238875     History of Changes
Other Study ID Numbers: JCOG0403, C000000029
Study First Received: October 13, 2005
Last Updated: February 2, 2009
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014