Unique ID issued by UMIN | C000000029 |
---|---|
Receipt number | R000000063 |
Scientific Title | A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403) |
Date of disclosure of the study information | 2005/07/28 |
Last modified on | 2015/11/20 14:20:52 |
A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Japan |
T1N0M0 non-small cell lung cancer
Radiology |
Malignancy
NO
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Efficacy
Exploratory
Phase II
3-years overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
stereotactic body radiation therapy
20 | years-old | <= |
Not applicable |
Male and Female
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
1. No apparent interstitial pneumonitis and fibrosis
2. No active inflamation without oral drugs
3. No double cancer
4. No pregnancy
5. No psychiatric disorder
6. No steroid administration
169
1st name | |
Middle name | |
Last name | Masahiro Hiraoka, M.D., P.h.D. |
Kyoto Universlty Hospital
Dept. of Radiation Oncology and Image-applied Therapy
54 Kawahara-cho,Shogoin, Sakyo, Kyoto, 606-8507 Japan
1st name | |
Middle name | |
Last name | Yasushi Nagata, M.D. |
JCOG0403 Coordinating Office
Division of Radiation Oncology, Hiroshima University Hospital
1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan 734-8551
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
Japan
YES
NCT00238875
ClinicalTrials.gov by NLM
北海道大学病院(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
がん・感染症センター都立駒込病院(東京都)
東京女子医科大学(東京都)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
北里大学医学部(神奈川県)
山梨大学医学部(山梨県)
京都大学医学部附属病院(京都府)
先端医療センター(兵庫県)
広島大学病院(広島県)
九州大学病院(福岡県)
2005 | Year | 07 | Month | 28 | Day |
Published
http://www.redjournal.org/article/S0360-3016(15)03069-2/abstract
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Main results already published
2004 | Year | 06 | Month | 24 | Day |
2004 | Year | 07 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2005 | Year | 07 | Month | 27 | Day |
2015 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000063
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |