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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033257
Receipt No. R000037840
Official scientific title of the study A positive clinical trial of carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.
Date of disclosure of the study information 2018/07/03
Last modified on 2018/07/10

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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