UMIN-CTR Clinical Trial

Basic information
Public title	Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Acronym	Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Scientific Title	Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Scientific Title:Acronym	Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Region	Japan

Condition
Condition	Solitary lymph node recurrence
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and toxicity of carbon-ion radiotherapy for solitary lymph node recurrence, retrospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year local control, course-specfic survival, and overall survival rates. Incidence of Grade 2 or worse late toxicities
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among patients who underwent carbon-ion radiotherapy in participating facilities between December 1996 and December 2015, patients who meet the following eligible criteria. 1) Patients who had diagnosed histologically or clinically as solitary lymph node recurrence. 2) Recurrence in single one lymph node region. 3) Lymph node recurrence could be included in an irradiation field. 4) There are no other recurrent lesions except the lymph node recurrence. 5) Tumor diameter could be measured by CT or MRI. 6) The age at starting of the carbon-ion radiotherapy was 20 years old and older. 7) Carbon-ion radiotherapy was administered to the lymph node recurrence.
Key exclusion criteria	1)Tumor invasion to GI tract. 2)Severe or active nfections in the irradiated area. 3)Severe concomitant illness.
Target sample size	310

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Kamada
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
Zip code	263-8555
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3306
Email	kamada.tadashi@qst.go.jp

Public contact
Name of contact person	1st name Okonogi Middle name Last name Okonogi
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
Zip code	263-8555
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3306
Homepage URL
Email	okonogi.noriyuki@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	Gunma University Heavy Ion Medical Center Hyogo Ion Beam Medical Center Ion Beam Therapy Center, SAGA HIMAT Foundation
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Certified Review Board, National Institutes for Quantum and Radiological Sciences and Technology
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel	043-206-4709
Email	helsinki@qst.go.jp

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 05 Month 10 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687700/pdf/10147_2019_Article_1440.pdf
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687700/pdf/10147_2019_Article_1440.pdf
Number of participants that the trial has enrolled	323
Results	A total of 323 patients were enrolled. The 2-year local control (LC) and overall survival (OS) rates after C-ion RT were 85% and 63%, respectively. Only 1 patient developed grade 3 toxicity. Factors such as LN diameter, histology, and history of previous RT did not correlate with LC. Smaller diameters (<30 mm) and numbers of LN metastases as well as longer disease-free intervals post-primary therapy were associated with significantly better OS.
Results date posted	2021 Year 06 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 04 Month 09 Day
Baseline Characteristics	See the abstract/PDF above
Participant flow	See the abstract/PDF above
Adverse events	See the abstract/PDF above
Outcome measures	See the abstract/PDF above
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 27 Day
Date of IRB	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is a retrospective multicenter observational study of carbon-ion radiotherapy for solitary lymph node recurrence. Among patients who underwent carbon-ion radiotherapy in participating facilities between December 1996 and December 2015, patients who meet the following eligible criteria are enrolled in this study. Eligible criteria: 1) Patients who had diagnosed histologically or clinically as solitary lymph node recurrence. 2) Recurrence in single one lymph node region. 3) Lymph node recurrence could be included in an irradiation field. 4) There are no other recurrent lesions except the lymph node recurrence. 5) Tumor diameter could be measured by CT or MRI. 6) The age at starting of the carbon-ion radiotherapy was 20 years old and older. 7) Carbon-ion radiotherapy was administered to the lymph node recurrence. Exclusion criteria: 1)Tumor invasion to GI tract. 2)Severe or active nfections in the irradiated area. 3)Severe concomitant illness.

Management information
Registered date	2017 Year 05 Month 10 Day
Last modified on	2021 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031231