UMIN-CTR Clinical Trial

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
Email	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
Email	yamada.shigeru@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037229