UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023183
Receipt No. R000026513
Official scientific title of the study A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer
Date of disclosure of the study information 2016/08/01
Last modified on 2017/06/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer
Title of the study (Brief title) A clinical study comparing carbon-ion radiotherapy and surgery for non-small cell lung cancer(iROCK-1504LU)
Region
Japan

Condition
Condition Small-sized peripheral non-small cell lung cancer with clinical stage IA
Classification by specialty
Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of carbon-ion radiotherapy for small-sized peripheral non-small cell lung cancer with clinical stage IA comparing to surgical removal
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Five-year overall survival
Key secondary outcomes a) Relapse-free survival, Cause-specific survival
b) Local recurrence
c) Adverse reaction
d) Respiratory function post-surgery or carbon-ion therapy
e) Length of hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Carbon-ion therapy
Interventions/Control_2 Surgical removal
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
79 years-old >=
Gender Male and Female
Key inclusion criteria All patients meet the following criteria(a-j).
(a)Contrast-enhanced thoracic CT fulfills all of the following conditions
(1)single tumor
(2)non-small cell lung cancer
(3)Center of tumor is located in the outer third of the peripheral lung field
(4)no finding of metastasis of reginal lymph node
(b)Thin-section CT fulfills either following conditions
(1)maximum diameter of the tumor is 2cm or less
(2)less than 3cm of the tumor size and less than 0.5 of consolidation tumor ratio
(c)Age 20 to 79 years old
(d)No prior ipsilateral thoracotomy
(e)No prior chemotherapy or radiation therapy for any malignant diseases
(f)Lobectomy tolerable
(g)0 or 1 of performance status
(h)Sufficient organ functions
(i)38centigrade or less of preoperative body temperature
(j)Written informed consent obtained
Key exclusion criteria All patients must NOT meet the following criteria.
a)Active bacterial or fungous infection
b)Simultaneous or metachronous (within the past 5 years) double cancers
c)Women during pregnancy or breast-feeding
d)Interstitial pneumonia, lung fibrasis or severe emphysema
e)Psychosis or psychiatric condition unsuitable for carbon-ion ratiotherapy or surgery
f)Systemic steroids medication
g)Intractable diabetes mellitus.
h)Intractable hypertension
i)History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months
j)Metal devices in the lesion
k)Other medical or psychological condition which is unsuitable for carbon-ion radio therapy or surgery
Target sample size 525

Research contact person
Name of lead principal investigator Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Email tnomiya@kcch.jp

Public contact
Name of contact person Dr. Takuma Nomiya
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Ion-beam Radiation Oncology Center
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Homepage URL
Email tnomiya@kcch.jp

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Funding Source
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

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 神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 30 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 07 Month 15 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026513

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form