UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048760 |
|---|---|
| Receipt number | R000055549 |
| Scientific Title | Phase II trial of preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer |
| Date of disclosure of the study information | 2022/08/26 |
| Last modified on | 2023/02/25 13:57:12 |
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Basic information
Public title
Phase II trial of preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer
Acronym
Phase II trial of preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer
Scientific Title
Phase II trial of preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer
Scientific Title:Acronym
Phase II trial of preoperative chemoradiotherapy using intensity-modulated radiotherapy for locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Locally advanced rectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore whether IMRT reduces the acute grade 2 diarrhea in preoperative chemoradiotherapy for locally advanced rectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grade 2 Acute diarrhea
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intensity-modulated radiotherapy (1.8 Gy/fr, 45-50.4Gy), Capecitabine 1650 mg/m2/day oral administration on the day of 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) Histologically confirmed rectal adenocarcinoma
2) Following three criteria was met,
i) Palpable by digital examination or within 12 cm from anal verge
ii) Positive circumferential resection margin or clinical T3-4N0 or T1-4N1-2
iii) No peritoneal, hepatic and lung metastasis
3) >=20 years old
4) Performance Status 0-2
5) No history of pelvic radiotherapy
6) Adequate organ function
Neutrophil count >= 1500/mm3
Platelet count >=100 000/mm3
Total bilirubin <=1.5 ULN
Both serum aspartate aminotransferase and alanine aminotransferase <=100 IU/L
CCr >= 30 ml/min/body
7) Able to intake orally
8) Grade 0-1 diarrhea
9) Written consent to participate in the current trial
Key exclusion criteria
1) Uncontrollable comorbidity (diarrhea, interstitial pneumonia, collagen vascular disease,diabetes mellitus, heart failure etc)
2) Pregnant or child-bearing potential, lactating patients
3) History of hypersensitivity to capecitabine or 5-fluorouracil
4) Currently taking tegafur/Gimeracil/Oteracil or within 7 days after discontinuation
5) Considered to be difficult to participate the current trial from psychotic disorders
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School and Faculty of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
6068507
Address
54, Shogoinn, Sakyo-ku,Kyoto, Kyoto
TEL
0757513762
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 and Faculty of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
6068507
Address
54, Shogoinn, Sakyo-ku,Kyoto, Kyoto
TEL
0757513762
Homepage URL
sakanaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
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 606-8501, JAPAN
Tel
075-753-4680
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
| 2022 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055549
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| Registered date | File name |
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