UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent or Metastatic Lung Tumors
Title of the study (Brief title)	Carbon-Ion Radiotherapy for Re-Irradiation
Region	Japan

Condition
Condition	Lung cancer or metastatic lung tumor
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the toxicity and efficacy of re-irradiation with CIRT for locoregionally recurrent, metastatic, or secondary lung tumors
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Toxicity
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	0 years-old <=
Age-upper limit	999 years-old >=
Gender	Male and Female
Key inclusion criteria	1) patients who received re-irradiation with CIRT 2) measurable tumors 3) a performance status of 0-2 4) no systemic therapy, such as chemotherapy, within 1 month of commencing re-irradiation with CIRT 5) an estimated life expectancy of more than 6 months
Key exclusion criteria	The presence of other primary cancers
Target sample size	95

Research contact person
Name of lead principal investigator	Kazuhiko Hayashi
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3360
Email	hayashi.kazuhiko@qst.go.jp

Public contact
Name of contact person	Kazuhiko Hayashi
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3360
Homepage URL
Email	hayashi.kazuhiko@qst.go.jp

Sponsor
Institute	Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization	Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 27 Day
Anticipated trial start date	2017 Year 10 Month 09 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29498145
Results	Data of 95 patients with prior intrathoracic carbon-ion radiotherapy who were treated with reirradiation with carbon-ion radiotherapy at our institution between 2006 and 2016 were retrospectively analyzed. Regarding severe toxicities, 1 patient experienced each of the following. Grade 5 bronchopleural fistula, Grade 4 radiation pneumonitis, Grade 3 chest pain, and Grade 3 radiation pneumonitis. The 2-year local control and overall survival rates were 54.0% and 61.9%, respectively. In conclusion, reirradiation with carbon-ion radiotherapy was associated with relatively low toxicity and moderate efficacy.
Other related information	None

Management information
Registered date	2017 Year 09 Month 27 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033511