Clinical trial NCT00238875: A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Official title: A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T1N0M0 Non-small Cell Lung Cancer
Keywords: stereotactic body radiation therapy
T1N0M0 non-small cell lung cancer
radiotherapy
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-10-14
Enrollment: 167
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 3-years overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: Overall survival
timeFrame: During the study conduct
measure: relapse-free survival
timeFrame: During the study conduct
measure: local-relapse free survival
timeFrame: During the study conduct
measure: 3-years local relapse free survival
timeFrame: During the study conduct
measure: patterns of relapse
timeFrame: During the study conduct
measure: acute complications
timeFrame: within 8 weeks from starting treatment day
measure: late complications
timeFrame: after 8 weeks from starting treatment day
measure: serious complication rate
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Fukuoka,Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Hiroshima,Minami-ku,Kasumi,1-2-3
country: Japan
facility: Hiroshima University, School of Medicine
state: Hiroshima
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: S-1,W-16,Chuo-ku,Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Kobe,Chuo-ku,Minatojima-Minamimachi,2-2
country: Japan
facility: Institute of Biomedical Research and Innovation Hospital
state: Hyogo
city: Sagamihara,Kitasato,1-15-1
country: Japan
facility: Kitasato University School of Medicine
state: Kanagawa
city: Kyoto,Sakyoku,Shogoin,Kawahara-cho,54
country: Japan
facility: Kyoto Universlty Hospital
state: Kyoto
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Tenri,Mishima-cho,200
country: Japan
facility: Tenri Hospital
state: Nara
city: Bunkyo-ku,Hongo,7-3-1
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Bunkyo-ku,Honkomagome,3-18-22
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Itabashi-ku,Oyaguchikamimachi,30-1
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinjuku-ku,Kawada-cho,8-1
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Nakakoma,Tamaho,Shimokato,1110
country: Japan
facility: University of Yamanashi Faculty of Medicine
state: Yamanashi
Study officials:
affiliation: Kyoto Universlty Hospital
name: Masahiro Hiraoka, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Nagata Y, Hiraoka M, Shibata T, Onishi H, Kokubo M, Karasawa K, Shioyama Y, Onimaru R, Kozuka T, Kunieda E, Saito T, Nakagawa K, Hareyama M, Takai Y, Hayakawa K, Mitsuhashi N, Ishikura S. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Int J Radiat Oncol Biol Phys. 2015 Dec 1;93(5):989-96. doi: 10.1016/j.ijrobp.2015.07.2278. Epub 2015 Nov 11.