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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044067
Receipt No. 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

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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
Email 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
Email h-doi@med.kindai.ac.jp

Sponsor
Institute Kindai University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050308

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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