UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033688
Receipt number R000038408
Scientific Title 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 2020/08/13 23:10:33

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Basic information

Public title

Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery

Acronym

Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery

Scientific Title

Retrospective observational study on adjuvant chemotherapy after advanced lower rectal cancer surgery

Scientific Title:Acronym

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

1st name Mitsuyoshi
Middle name
Last name Ota

Organization

Yokohama City University Medical Center

Division name

Department of Surgery, Gastroenterological Center

Zip code

2320024

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

1st name Kazuya
Middle name
Last name Nakagawa

Organization

Yokohama City University Medical Center

Division name

Department of Surgery, Gastroenterological Center

Zip code

2320024

Address

4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

nakagawakazuya0827@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Ethics committee of Yokohama City University

Address

3-9 Fukuura, Kanazawa-Ku, Yokohama

Tel

045-370-7627

Email

nextjim1@yokohama-cu.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

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


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

845

Results

Of 811 patients, 401 patients (49.4%) received adjuvant chemotherapy after surgery.

Results date posted

2020 Year 08 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Of 811 patients, 530 patients were male and 281 were female. The median age of the patients was 67 years. Pathological stage was pStage II in 341 patitents and pStage III in 470 patients.

Participant flow

Medical reports from 845 patients were collected from 13 hospitals. Of these, 34 were excluded from the analysis because radical resection could not complete. The remaining 811 patients were analyzed.

Adverse events

None

Outcome measures

rate of adjuvant chemotherapy

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 29 Day

Date of IRB

2015 Year 08 Month 01 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

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

2020 Year 08 Month 13 Day



Link to view the page

Value
https://center6.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