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Name:
UMIN ID:

Recruitment status Recruiting
Unique ID issued by UMIN UMIN000022731
Receipt No. R000025839
Official scientific title of the study 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 2016/06/14

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Basic information
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation
Title of the study (Brief title) 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.Without distant metastases by CT, MRI and PET findings
4. 20 years or older
5. Performance status between 0 and 2
6. Normal function of main organs
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.
Target sample size 71

Research contact person
Name of lead principal investigator Shigeru Yamada
Organization National Institute of Radiological Sciences
Division name hospital
Address 4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL 043-206-3306
Email yamada.shigeru@qst.go.jp

Public contact
Name of contact person Adviser
Organization National Institute of Radiological Sciences
Division name hospital
Address 4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL 043-284-8852
Homepage URL
Email yamada.shigeru@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
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 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

Progress
Recruitment status Recruiting
Date of protocol fixation
2016 Year 05 Month 16 Day
Anticipated trial start date
2016 Year 06 Month 10 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
2016 Year 06 Month 14 Day
Last modified on
2016 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025839

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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