UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027300 |
|---|---|
| Receipt number | R000031231 |
| Scientific Title | Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2021/06/08 18:48:02 |
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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
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
okonogi.noriyuki@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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031231
