UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024549 |
|---|---|
| Receipt number | 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 | 2022/04/29 09:40:26 |
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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 | 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
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
sakanaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028242
