UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A positive clinical trial of carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.
Title of the study (Brief title)	Carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.(iROCK-1703LU)
Region	Japan

Condition
Condition	Peripherally located stage-I non small cell lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of carbon-ion radiotherapy for the patients with locally advanced peripherally located stage-I non small cell lung cancer in Kanagawa Cancer Center
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Proportion of patients who developed glade 2 or early severe adverce events related to lung and skin
Key secondary outcomes	1) Local progression free survival 2) Overall survival 3) Adverse event rate 4) Progression free survival 5) 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	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Carbon-ion radiotherapy 1) Based on a total dose of 60.0 Gy(RBE), 54.0 to 64.0 Gy(RBE) / 4 fractions 2) A total dose of 50.0 Gy(RBE) / 1 fraction 3) A total dose of 64.0 to 72.0 Gy(RBE) / 12 to 16 fractions(When the division mentioned above is difficult for the dose limitation of the neighboring organ)
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 or clinically diagnosed NSCLC 2) Clinically IA-IB diagnosed by imaging examnations including FDG-PET, and peripherally located (2017, UICC 8th) 3) Patients who are judged to be unable to resect lobectomy* by examination with a cancer board including doctors of thoracic surgeon, respiratory medicine and radiation oncologst it is judged that patients can be operated or surgery is possible, but patients who hope carbon-ion radiotherapy *The case of not satisfying even one of this conditions (a) to (f) below shall be defined as inoperable in this study. (a) Postopenative prognosis FEV1.0 > 800ml (b) PaO2 > 65mmHg or SaO2 > 92% (C) 0 to 1 of performance status (ECOG) (d) There is enough cardiac activity, the patients who are judged as operable (e) There is not diabetes that it is hard to control with insulin (f) No severe complications, the patients who are judged as operable 4) Exist of lesion for evaluation 5) Initial treatment for the lesion 6) 0 to 2 of performance status (ECOG) 7) Aged 20 or above at the time of registration 8) Patient who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B) 9) Written concent obtained for the participation in this study
Key exclusion criteria	1) Severe comorbidities including infection and mental disorders 2) Interstitial pneumonitis on CT images 3) Patient with active double cancer, active and untreated double cancer, except for intraepithelial carcinoma, intramucinous carcinoma or malignancy controlled for a long-term 4) Interstitial pneumonitis on CT images 5) Pregnant women, women who may become pregnant 6) When it is not possible to confirm the intention of the person by the decline of cognitive function 7) Medically or psychologically unsuitable conditions
Target sample size	162

Research contact person
Name of lead principal investigator	Dr. Daisaku Yoshida
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Radiation Oncology
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL	045-520-2222
Email	d.yoshida@kcch.jp

Public contact
Name of contact person	Dr. Daisaku Yoshida
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, JAPAN
TEL	045-520-2222
Homepage URL
Email	d.yoshida@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	Japan

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

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	2018 Year 07 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 29 Day
Anticipated trial start date	2018 Year 07 Month 10 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	2018 Year 07 Month 03 Day
Last modified on	2018 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037840