UMIN-CTR Clinical Trial

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

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Basic information

Public title

A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)

Acronym

A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)

Scientific Title

A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)

Scientific Title:Acronym

A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)

Region

Japan


Condition

Condition

T1N0M0 non-small cell lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3-years overall survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

stereotactic body radiation therapy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key exclusion criteria

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

Target sample size

169


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Hiraoka, M.D., P.h.D.

Organization

Kyoto Universlty Hospital

Division name

Dept. of Radiation Oncology and Image-applied Therapy

Zip code


Address

54 Kawahara-cho,Shogoin, Sakyo, Kyoto, 606-8507 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Nagata, M.D.

Organization

JCOG0403 Coordinating Office

Division name

Division of Radiation Oncology, Hiroshima University Hospital

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan 734-8551

TEL


Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00238875

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2005 Year 07 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.redjournal.org/article/S0360-3016(15)03069-2/abstract

Number of participants that the trial has enrolled


Results

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

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2004 Year 06 Month 24 Day

Date of IRB


Anticipated trial start date

2004 Year 07 Month 01 Day

Last follow-up date

2017 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 07 Month 27 Day

Last modified on

2015 Year 11 Month 20 Day



Link to view the page

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