UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023398
Receipt number R000023120
Scientific Title Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer
Date of disclosure of the study information 2016/11/01
Last modified on 2022/08/05 08:53:52

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Basic information

Public title

Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer

Acronym

Multi-institutional Clinical Trial of C-ion RT for Peripherally Stage-I NSCLC

Scientific Title

Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer

Scientific Title:Acronym

Multi-institutional Clinical Trial of C-ion RT for Peripherally Stage-I NSCLC

Region

Japan


Condition

Condition

Peripherally located inoperable stage-I non-small-cell lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of Carbon-ion radiotherapy for peripherally located inoperable stage I non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

3-year overall survival rate

Key secondary outcomes

Toxicities
Median survival time
2-year overall survival rate
2- and 3-year cause-specific survival rate
2- and 3-year progression-free survival rate
2- and 3-year local-progression-free rate
2- and 3-year local-progression-free survival rate
Pattern of recurrences


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

Device,equipment Maneuver

Interventions/Control_1

Carbon-ion radiotherapy
60.0GyRBE/4fractions (15.0GyRBE/fraction)

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Pathologically confirmed or clinically diagnosed NSCLC
2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET, and peripherally located
3)Considered to be unfit to lobar resection by cancer board including thoracic surgeon, pulmonary medical oncologist and radiation oncologist
4)Exist of lesion for evaluation
5)Initial treatment for the lesion
6)PS(ECOG) 0-2
7)SpO2 >= 90% or PaO2 >= 60 torr(mmHg)
8)FEV1.0 >= 700ml
9)>= 20 years-old / =< 90 years-old
10)Written informed consent

Key exclusion criteria

1)Severe comorbidities including infection and mental disorders
2) Interstitial pneumonitis on CT images
3)Coexisting malignancies within 2 years excepting Carcinoma in situ, stage-I laryngeal cancer, stage-I prostate cancer and stage-I breast cancer
4)History of thoracic irradiation
5)Pregnancy
6)Enrolled in other clinical trials with Interventions
7)Other reasons judged by physician

Target sample size

150


Research contact person

Name of lead principal investigator

1st name hiroaki
Middle name
Last name suefuji

Organization

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Division name

Department of Radiation Oncology

Zip code

841-0071

Address

3049 Harakoga-machi, Tosu, Japan

TEL

0942-81-1897

Email

sufg@saga-himat.jp


Public contact

Name of contact person

1st name hiroaki
Middle name
Last name suefuji

Organization

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Division name

Department of Radiation Oncology

Zip code

841-0071

Address

3049 Harakoga-machi, Tosu, Japan

TEL

0942-81-1897

Homepage URL


Email

1501lung@saga-himat.jp


Sponsor or person

Institute

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ion Beam Therapy Center, SAGA-HIMAT Foundation Institutional Review Board

Address

3049 Harakoga-machi, Tosu, Japan

Tel

0942-81-1897

Email

saga-himat@saga-himat.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

J-CROS 1501 LUNG

Org. issuing International ID_1

Japan Carbon-ion Radiation Oncology Study Group

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

九州国際重粒子線がん治療センター(佐賀県)、QST病院(千葉県)、群馬大学重粒子医学研究センター(群馬県)、兵庫県立粒子線医療センター(兵庫県)、神奈川県立がんセンター(神奈川県)、大阪重粒子線センター(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 05 Day

Date of IRB

2022 Year 08 Month 01 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2027 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 29 Day

Last modified on

2022 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name