UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033257 |
|---|---|
| Receipt number | R000037840 |
| Scientific Title | 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 14:05:20 |
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Basic information
Public title
A positive clinical trial of carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.
Acronym
Carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.(iROCK-1703LU)
Scientific Title
A positive clinical trial of carbon-ion radiotherapy for peripherally located stage-I non small cell lung cancer.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Dr. Daisaku Yoshida |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Radiation Oncology
Zip code
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL
045-520-2222
d.yoshida@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Daisaku Yoshida |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Ion-beam Radiation Oncology Center
Zip code
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN
TEL
045-520-2222
Homepage URL
d.yoshida@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
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037840
