UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047191 |
|---|---|
| Receipt number | R000053831 |
| Scientific Title | Management and Treatment for Radiation-Induced Colitis |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2022/03/17 14:08:05 |
* 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
Management and Treatment for Radiation-Induced Colitis
Acronym
MATRICS
Scientific Title
Management and Treatment for Radiation-Induced Colitis
Scientific Title:Acronym
MATRICS
Region
| Japan |
Condition
Condition
Locally recurrent colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the frequency and severity of radiation-induced colitis that occurs after heavy ion therapy in patients with locally recurrent colorectal cancer with a high degree of proximity or invasion of the tumor to the gastrointestinal tract.
Based on the appropriate endoscopic observation and evaluation of the colitis, we evaluate the safety of surgical treatment for those cases in which it is indicated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and severity of radiation-induced colitis that occurs within two years after heavy ion therapy
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Heavy-ion radiation therapy 73.6Gy/16fr/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) Locally recurrent colorectal diseases.
2) Tumor invades or is in close proximity to the gastrointestinal tract, and the site can be observed by colonoscopy.
3) The tumor is not indicated for curative resection.
4) Surgeons at the collaborating institution have previously evaluated that resection of the damaged gastrointestinal tract is feasible.
5) The patient has no distant metastases or has only metastatic lesions that are scheduled for resection.
6) Be at least 20 years of age at the time of enrollment.
7) Patient has a performance status (ECOG) of 0-1.
8) Main organ function is preserved.
9) Written consent for participation in this study has been obtained from the patient.
Key exclusion criteria
1) Patients who are considered to be unable to undergo the prescribed hospital visits and examinations.
2) Patients who are receiving chemotherapy or who have not completed chemotherapy within 2 weeks of the start of irradiation.
3) Patients with open wounds or active, refractory infections in the irradiated area.
4) Patients have active multiple cancers.
5) Patients with serious complications.
6) Patients with mental illness or psychiatric symptoms that would make participation in the clinical research difficult or adults who are incapable of consenting.
(7) Patients who are considered to be unsuitable for enrollment in this study by the physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Takiyama |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba City, Chiba Pref.
TEL
0432063306
takiyama.hirotoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Takiyama |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba City, Chiba Pref.
TEL
0432063306
Homepage URL
takiyama.hirotoshi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage, Chiba City, Chiba Pref.
Tel
043-206-4706
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
国立国際医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053831
