UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023076
Receipt number R000026598
Scientific Title A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer
Date of disclosure of the study information 2016/07/08
Last modified on 2016/07/08 12:57:18

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Basic information

Public title

A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

Acronym

A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

Scientific Title

A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

Scientific Title:Acronym

A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

Region

Japan


Condition

Condition

Centrally located 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 centrally located stage I non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

3-year local control rate

Key secondary outcomes

3- and 5-year overall survival rate
3- and 5-year cause-specific survival rate
3- and 5-year progression-free survival rate
Toxicities
Pulmonary function (VC, FEV1.0) at 3 years


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Carbon-ion radiotherapy
68.4GyRBE/12fractions

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)Pathologically confirmed NSCLC
2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET
3)No history of thoracic irradiation
4)Medically inoperable or refuse surgery
5)Exist of lesion for evaluation
6)Centrally located
7)No history of chemotherapy within 2 weeks
8)20 year-old or > 20 year-old
9) PS(ECOG)0-2
10)Estimated survival longer than 6 months
11)Writtened informed consent

Key exclusion criteria

1)Interstitial pneumonitis on CT images
2)< SpO2 94%
3)Severe infections in treatment area
4)Coexisting malignancies within 2 years excepting Carcinoma in Situ, stgae I laryngeal cancer, localized prostate cancer
5)Pregnancy
6)Unfit due to mental disorders
7)Continuouslly oral or intravenous administration of steroid
8)Other reasons judged by physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyuki Shioyama

Organization

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Division name

Department of Radiation Oncology

Zip code


Address

3049 Harakoga-machi, Tosu, Japan

TEL

0942-81-1897

Email

shioyama-yoshiyuki@saga-himat.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiyuki Shioyama

Organization

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Division name

Department of Radiation Oncology

Zip code


Address

3049 Harakoga-machi, Tosu, Japan

TEL

0942-81-1897

Homepage URL


Email

shioyama-yoshiyuki@saga-himat.jp


Sponsor or person

Institute

Ion Beam Therapy Center, SAGA-HIMAT Foundation

Institute

Department

Personal name



Funding Source

Organization

Nne

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


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 08 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

2014 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date


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 08 Day

Last modified on

2016 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026598


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name