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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033688
Receipt No. R000038408
Official scientific title of the study Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery
Date of disclosure of the study information 2018/08/09
Last modified on 2018/08/08

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Basic information
Official scientific title of the study Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery
Title of the study (Brief title) Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery
Region
Japan

Condition
Condition Advanced rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the proportion and efficacy of adjuvant chemotherapy after advanced lower rectal cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Implementation rate of adjuvant chemotherapy
Key secondary outcomes 1)Regimen, period of administration, total dose of adjuvant chemotherapy
2)Adverse event of adjuvant chemotherapy
3)Reasons for not performingen adjuvant chemotherapy after surgery
4)Relapse-free survival, overall survival, local recurrence rate
5)Risk factors for local recurrence
6)Risk factors for anastomatic leakage
7)Risk factors for postoperative urinary disorder

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)Patient who underwnet rectal cancer surgery between 2008 and 2012
2)Tumor distal edge was located below peritoneal reflection
3)Pathological T3/T4 or N1/N2/N3
4)No distant metastasis
Key exclusion criteria 1)Patient who performed preoperative treatment (chemotherapy, radiotherapy, chemoradiotherapy)
2)Petients who are considered to be inappropriate for this trial by doctor
Target sample size 1000

Research contact person
Name of lead principal investigator Ota Mitsuyoshi
Organization Yokohama City University Medical Center
Division name Department of Surgery, Gastroenterological Center
Address 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan
TEL 045-261-5656
Email m_ota@yokohama-cu.ac.jp

Public contact
Name of contact person Nakagawa Kazuya
Organization Yokohama City University Medical Center
Division name Department of Surgery, Gastroenterological Center
Address 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email nakagawakazuya0827@yahoo.co.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Yokohama Clinical Oncology Group (YCOG)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 横浜市立大学附属病院(神奈川県)、横浜市立市民病院(神奈川県)、横浜市南部病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、横浜医療センター(神奈川県)、保土ヶ谷中央病院(神奈川県)、えきさい会病院(神奈川県)、若草病院(神奈川県)、横須賀共済病院(神奈川県)、横須賀市立市民病院(神奈川県)、藤沢市民病院(神奈川県)、NTT東日本関東病院(東京都)、伊東市民病院(静岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 09 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 05 Month 29 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information To investigate the proportion and efficacy of adjuvant chemotherapy after advanced lower rectal cancer surgery

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038408

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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