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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032650
Receipt No. R000037229
Official scientific title of the study 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 2018/06/07

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Basic information
Official scientific title of the study A clinical trial for efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancer
Title of the study (Brief title) 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 TADASHI KAMADA
Organization National Institute of Radiological Sciences
Division name HOSPITAL
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 Yamada Shigeru
Organization National Institute of Radiological Sciences
Division name Hospital
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Anticipated trial start date
2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 05 Month 20 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037229

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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