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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024549
Receipt No. R000028242
Scientific Title Preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer: single institutional pilot study
Date of disclosure of the study information 2016/11/01
Last modified on 2018/10/26

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Basic information
Public title Preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer: single institutional pilot study
Acronym Preoperative chemoradiotherapy using IMRT for locally advanced rectal cancer: pilot study
Scientific Title Preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer: single institutional pilot study
Scientific Title:Acronym Preoperative chemoradiotherapy using IMRT for locally advanced rectal cancer: pilot study
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to evaluate whether IMRT reduces the acute toxicity in the preoperative chemoradiotherapy for rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of grade 2 acute gastrointestinal toxicity
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
Medicine Device,equipment
Interventions/Control_1 1) Preoperative chemoradiotherapy
i) Intensity-modulated radiotherapy: 45 Gy/25frs/5weeks
ii) S-1 80-120mg/body, p.o (days 1-5, 8-12, 22-26, 29-33), CPT-11, 60 mg/m2, div (days 1, 8, 22, 29)
2) Operation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed adenocarcionma
2) Resectable rectal cancer
i) clinically T3-4 and N0-2
ii) Ra or Rb
iii) Inferior margin of tumor is located below the peritoneal reflection
3) No hepatic, peritoneal metastasis
4) 20-80 years
5) Performance Status: 0-2
6) No previous treatment
7) Adequate organ function
8) Able to take drugs orally
9) Written informed consent
Key exclusion criteria 1) Active other synchronous cancer
2) Receiving flucytosin or atazonavi
3) Suffering the active infection
4) Uncontrollable comorbidity
5) Pregnant or breastfeeding women,
6) Reciving steroid medication
7) Difficult to join due to mental disorder
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto university graduate school of medicin
Division name Department of radiation oncology and image-applied therapy
Zip code
Address 54 Sho-goinn Kawahara cho, Sakyoku, Kyoto, Kyoto
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Sakanaka
Organization Kyoto university graduate school of medicine
Division name Department of radiation oncology and image-applied therapy
Zip code
Address 54 Sho-goinn Kawahara cho, Sakyoku, Kyoto, Kyoto
TEL 075-751-3762
Homepage URL
Email sakanaka@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, 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
Address
Tel
Email

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 11 Month 01 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
Date of protocol fixation
2016 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028242

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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