UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044067 |
|---|---|
| Receipt number | R000050308 |
| Scientific Title | Preoperative radiotherapy for advanced rectal cancer: a prospective observational study |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2021/04/28 15:33:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preoperative radiotherapy for advanced rectal cancer: a prospective observational study
Acronym
Preoperative radiotherapy for rectal cancer: a prospective observational study
Scientific Title
Preoperative radiotherapy for advanced rectal cancer: a prospective observational study
Scientific Title:Acronym
Preoperative radiotherapy for advanced rectal cancer: a prospective observational 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 safety and efficacy of preoperative radiotherapy for advanced rectal cancer in a prospective observational study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year local-regional control rate
Key secondary outcomes
cumulative local-regional control rate, relapse-free survival, overall survival, failure pattern, accumulated local recurrence rate, treatment completion rate, safety (operative complications, late adverse events), nutritional status, R0 resection rate, immunohistochemical assessment, down-staging rate, pathological response rate, response rate (RECIST version1.1), cCR, pCR, imaging, treatment planning, IGRT, errors in radiotherapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 adenocarcionma
2. Resectable rectal cancer with cT3-4N1-2M0-1 (UICC 8th ed.)
3. 20- years
4. Performance Status: 0-1
5. No previous pelvic radiotherapy
6. Written informed consent
Key exclusion criteria
1. Pregnant or breastfeeding women
2. Uncontrollable comorbidity
3. Previous pelvic radiotherapy
4. Other
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Nishimura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-0014
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
ynishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Doi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-0014
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
h-doi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
Tel
072-366-0221
h-doi@med.kindai.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
| 2021 | Year | 04 | Month | 28 | 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
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint: 2-year local-regional control rate
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050308
