UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032650 |
|---|---|
| Receipt number | R000037229 |
| Scientific Title | A clinical trial for efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancer |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2019/12/24 12:33:57 |
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Basic information
Public title
A clinical trial for efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancer
Acronym
recurrent rectal cancer
Scientific Title
A clinical trial for efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancer
Scientific Title:Acronym
recurrent rectal cancer
Region
| Japan |
Condition
Condition
Recurrent rectal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to examine efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate at 3 years
Key secondary outcomes
Overall survival
Progression-free survival
Toxicity
cost-effectiveness
Quality-of-life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Heavy-ion Particle Radiotherapy
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.confirmed pelvic recurrence of rectal cancer without distant metastasis 2.had radiographically measurable tumor 3.Age to obtain consent is over 20 yo 4. performance status (ECOG) of 0-2 5. CMP and CBC with adequate hematologic variables as defined by WBC>1000/mm3, platelets>25,000/mm3,Creatinine <1.5 mg/dL,AST and ALT < 2.5 X ULN 6. expected to survive over 3 months 7. All patients must be willing and capable to provide informed consent
Key exclusion criteria
1.Tumor exceeds 15 cm in greatest dimension 2. Subjects receiving other investigational agents they received chemotherapy within 4 weeks of CIRT3. they had an infection at the tumor site 4. The tumor is infiltrating the digestive tract or bladder 5. Prior radiation to the pelvis 6. resectable by radiographic 7. with distant metastasis 8. Active other cancer or within 2 years of disease free period after cancer treatment 9. serious complications 10. difficult to participate in clinical trials because of mental illness 11. Patients who doctors judged that clinical trial participation is inappropriate
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | TADASHI |
| Middle name | |
| Last name | KAMADA |
Organization
National Institute of Radiological Sciences
Division name
HOSPITAL
Zip code
263-8555
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL
043-206-3306
kamada.tadashi@qst.go.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institute of Radiological Sciences
Division name
Hospital
Zip code
260-8677
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL
043-206-3306
Homepage URL
yamada.shigeru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum and Radiological 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
National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inageku, Chiba
Tel
043-206-4706
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
J-CROS 1506
Org. issuing International ID_1
Japan Carbon-ion Radiation Oncology Study Group
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
21
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
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037229
