UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008167 |
|---|---|
| Receipt number | R000009618 |
| Scientific Title | Prospective observational study on efficacy and safety of carbon ion radiotherapy for solitary lymph-node recurrence |
| Date of disclosure of the study information | 2012/06/14 |
| Last modified on | 2021/06/08 14:39:28 |
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Basic information
Public title
Prospective observational study on efficacy and safety of carbon ion radiotherapy for solitary lymph-node recurrence
Acronym
Carbon ion radiotherapy for solitary lymph-node recurrence
Scientific Title
Prospective observational study on efficacy and safety of carbon ion radiotherapy for solitary lymph-node recurrence
Scientific Title:Acronym
Carbon ion radiotherapy for solitary lymph-node recurrence
Region
| Japan |
Condition
Condition
Lymph-node recurrence of malignant tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy and safety of 12-fractionated carbon ion radiotherapy for solitary lymph-node recurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate at 2 years
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
1) Histologically or clinically diagnosed lymph-node recurrence.
2) 1-3 recurrent lymph nodes.
3) Recurrent lymph nodes can be included in one irradiation field.
4) No recurrent lesions other than the recurrent lymph nodes.
5) Measurable tumors on CT or MRI.
6) Age 20 or above.
7) Performance status 0-2.
8) Informed consent is obtained.
Key exclusion criteria
1) Tumor invasion to gastro-intestinal tract.
2) Past history of chemotherapy within 4 weeks before treatment.
3) Uncontrolled infection within the region to be irradiated.
4) Past history of radiotherapy in the region to be irradiated.
5) Severe concomitant diseases.
6) Active concurrent cancers.
7) (Possibly) pregnant patients.
8) Other medically or psychologically unsuitable circumstances are present.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8378
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8378
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2012 | Year | 06 | Month | 14 | 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
| 2011 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2012 | Year | 06 | Month | 14 | 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=R000009618
