UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032911 |
|---|---|
| Receipt number | R000037461 |
| Scientific Title | A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2018/06/07 18:35:34 |
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Basic information
Public title
A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer
Acronym
Dose escalation study of Carbon Ion Radiotherapy for CLM
Scientific Title
A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer
Scientific Title:Acronym
Dose escalation study of Carbon Ion Radiotherapy for CLM
Region
| Japan |
Condition
Condition
Colon cancer liver metastasis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify the optimal dose of single fraction carbon-ion radiotherapy (CIRT) for colorectal cancer liver metastasis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute toxicity and initial tumor response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Prescribed heavy-ion beam (carbon-ion beam) dose.
Initial dose 36Gy(RBE). Dose escalated until dose limiting toxicity is met.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included patients who:
1. has colorectal cancer liver metastasis diagnosed by radiological and clinical findings
2. with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
3. had primary colorectal lesions and lymph node metastasis removed totally by surgery (R0 resection) at least 4 weeks prior to enrollment and primary lesions to be histologically proven as CRC
4. have not received chemotherapy for at least 4 weeks prior to enrollment.
Key exclusion criteria
This study excluded patients who:
1. has evident vascular invasion.
2. had prior treatment to the specific lesion,
3. with lesions close to the intestine (less than 5 mm),
4. with uncontrollable ascites,
5. with severe liver damage,
6. with active coexisting malignancy,
7. with extra-hepatic lesions including local recurrence
8. were pregnant.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Miyazaki |
Organization
Chiba University Graduate School of Medicine
Division name
General surgery
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba City
TEL
043-222-7171
masaru@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Makishima |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
National Institutes of Radiological Sciences
Zip code
Address
4-9-1 Anagawa Inage-ku, Chiba City
TEL
043-206-3306
Homepage URL
makishima.hirokazu@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 06 | Month | 07 | 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
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | 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
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037461
