UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029313
Receipt number R000033511
Scientific Title Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent or Metastatic Lung Tumors
Date of disclosure of the study information 2017/09/28
Last modified on 2018/03/29 08:30:47

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Basic information

Public title

Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent or Metastatic Lung Tumors

Acronym

Carbon-Ion Radiotherapy for Re-Irradiation

Scientific Title

Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent or Metastatic Lung Tumors

Scientific Title:Acronym

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

1st name
Middle name
Last name Kazuhiko Hayashi

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

Hospital of the National Institute of Radiological Sciences

Zip code


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

1st name
Middle name
Last name Kazuhiko Hayashi

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

Hospital of the National Institute of Radiological Sciences

Zip code


Address

Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan

TEL

043-206-3360

Homepage URL


Email

hayashi.kazuhiko@qst.go.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29498145

Number of participants that the trial has enrolled


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.

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

Completed

Date of protocol fixation

2017 Year 09 Month 27 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name