UMIN-CTR Clinical Trial

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
Email	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
Email	takiyama.hirotoshi@qst.go.jp

Sponsor
Institute	National Institutes for Quantum Science and Technology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053831