UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023183 |
|---|---|
| Receipt number | R000026513 |
| Scientific Title | 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 | 2023/12/26 13:56:44 |
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Basic information
Public title
A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer
Acronym
A clinical study comparing carbon-ion radiotherapy and surgery for non-small cell lung cancer(iROCK-1504LU)
Scientific Title
A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer
Scientific Title:Acronym
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
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Ion-beam Radiation Oncology Center
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
clinical_trials@kcch.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026513
