UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022731 |
|---|---|
| Receipt number | R000025839 |
| Scientific Title | A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation |
| Date of disclosure of the study information | 2016/06/14 |
| Last modified on | 2023/06/21 13:45:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation
Acronym
Carbon-ion re-irradiation for pelvic recurrent rectal cancer
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation
Scientific Title:Acronym
Carbon-ion re-irradiation for pelvic recurrent rectal cancer
Region
| Japan |
Condition
Condition
pelvic recurrent rectal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to asses carbon ion radiation therapy performed as re-irradiation in patients with locally recurrent rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3 years survival rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Heavy-ion particle irradaition
70.4Gy(RBE)/16fractions/4weeks
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. Confirmation of locally recurrent colorectal cancers in patients with prior carbon-ion irradiation
2. No invasion to digestive tracts, bladder or urethra
3.Not indicated for curative resection or does not wish to undergo surgery.
4.Has evaluable disease.
5.Without distant metastases by CT, MRI and PET findings
6. 20 years or older
7. Performance status between 0 and 2
8. Normal function of main organs
9.Presumed to be alive for at least 3 months.
10.Written consent to participate in this study has been obtained from the patient.
Key exclusion criteria
1. Diameter of treatment volume longer than 15cm
2.Patient receive chemotherapy within 2 weeks
3. If they have an open wound or a active inflammatory disease
4. If they have a concomitant malignancy
5. If they have a severe heart diseases, a severe cerebrovascular disorder, a severe diabetes, angina pectoris, cardiac infarction.
6.In appropriate for this clinical study because of mental disorder, or other severe concurrent disease.
7.Adults and minors who do not have the capacity to consent.
Target sample size
71
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institute for Quantum and
Radiological Sciences and Technology
Division name
QST Hospital
Zip code
206-8555
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL
043-206-3306
yamada.shigeru@qst.go.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institute for Quantum and Radiological Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
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 Institute for Quantum and
Radiological Sciences and Technology
QST hospital
Institute
Department
Personal name
Funding Source
Organization
National Institute for Quantum and
Radiological Sciences 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 Institute for Quantum and Radiological Sciences and Technology
Address
4-9-1 Anagawa, Inageku, Chiba, Japan
Tel
043-209-4706
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
| 2016 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025839
