UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001318
Receipt number R000001417
Scientific Title Randomized control trial of follow-up schedule after curative resection for colorectal cancer
Date of disclosure of the study information 2008/08/19
Last modified on 2009/02/23 10:19:23

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Basic information

Public title

Randomized control trial of follow-up schedule after curative resection for colorectal cancer

Acronym

Follow-up trial for colorectal cancer

Scientific Title

Randomized control trial of follow-up schedule after curative resection for colorectal cancer

Scientific Title:Acronym

Follow-up trial for colorectal cancer

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To make a standard interval of postoperative workups in Dukes A and Dukes B stages.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Five-year Overall survival

Key secondary outcomes

Rate of curative resection after recurrences

Total costs


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intensive postoperative follow-up schedule

Interventions/Control_2

standard postoperative follow-up schedule

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


Not applicable

Age-upper limit

76 years-old >

Gender

Male and Female

Key inclusion criteria

1. Dukes A and Dukes B
2. After curative resection for primary colorectal cancer.
3. Adenocarcinoma was pathologically proven.
4. Standard lymphadenectomy was performed.
5. <76 years old
6. Performance status=0 or 1
7. Follow-up will be possible at the same hospital where operations was performed.

Key exclusion criteria

1. Postoperative severe copmlications
2. Double cancers
3. Psychogenic disease
4. Informed consent was not gotten.
5. Not juded as eligible by attending physicians.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Moriya

Organization

National Cancer Center Hospital

Division name

Colorectal surgery

Zip code


Address

5-1-1, Tsukiji, Chuuouku, Tokyo, Japan

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Ito

Organization

National Cancer Center Hospital East

Division name

Department of colorectal and pelvic surgery

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Homepage URL


Email



Sponsor or person

Institute

Follow-up study group

Institute

Department

Personal name



Funding Source

Organization

This study was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health and Welfare and Labor of Japan.

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2008 Year 08 Month 19 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

No longer recruiting

Date of protocol fixation

2002 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2003 Year 09 Month 01 Day

Last follow-up date

2013 Year 08 Month 01 Day

Date of closure to data entry

2013 Year 10 Month 01 Day

Date trial data considered complete

2013 Year 10 Month 01 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 08 Month 18 Day

Last modified on

2009 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001417


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name