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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008167
Receipt No. 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 2015/01/08

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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
Last 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
Email tnakano@gunma-u.ac.jp

Public contact
1st 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
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

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
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
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
2015 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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