UMIN-CTR Clinical Trial

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 Takashi Middle name Last name Mizowaki
Organization	Kyoto university graduate school of medicin
Division name	Department of radiation oncology and image-applied therapy
Zip code	606-8507
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 Katsuyuki Middle name Last name Sakanaka
Organization	Kyoto university graduate school of medicine
Division name	Department of radiation oncology and image-applied therapy
Zip code	6068507
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4642
Email	ethcom@kuhp.kyoto-u.ac.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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
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	Main results already published
Date of protocol fixation	2016 Year 10 Month 24 Day
Date of IRB	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 01 Month 18 Day
Last follow-up date	2024 Year 01 Month 17 Day
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	2022 Year 04 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028242