UMIN-CTR Clinical Trial

Public title

Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin

Acronym

Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin (J-CAPP Study)

Scientific Title

Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin

Scientific Title:Acronym

Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin (J-CAPP Study)

Region

Japan

Condition

colorectal tumor

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the colorectal cancer preventive effect of aspirin enteric-coated tablet (100 mg, one tablet daily) in oriental people in a double-blind, randomized study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Only the occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Aspirin (100 mg/day) enteric-coated tablet

Interventions/Control_2

Placebo tablet / day

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

Candidate patients have to meet all the following inclusion criteria to participate in the study.
# Patients with at least one colorectal tumor (intramucosal cancer and adenoma) as confirmed by histological diagnosis, all of which have been removed endoscopically (at any time)
# Patients with known history of all endoscopic treatments (including histological diagnosis) of colorectal tumors
# Patients who have undergone total colonoscopy at least twice
# Patients with clean colon as confirmed by total colonoscopy within 3 months before the study

Key exclusion criteria

# Patients with a medical history of submucosal or deeper colorectal cancer.
# Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin.
# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
# Patients with familial colorectal adenoma.
# Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study)
# Patients with bleeding tendency, a platelet count of 150,000, or with abnormal PT
# Patients with any existing cancer at the time of participation in the study.
# Patients with known allergy to aspirin.
# Patients currently taking anticancer drugs.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.

Target sample size

700

Name of lead principal investigator

1st name	Sadao
Middle name
Last name	Suzuki

Organization

Nagoya City University Medical School

Division name

Department of Health Promotion and Preventive Medicine

Zip code

467-8602

Address

Mizuho-ku, Nagoya 467-8601

TEL

052-853-8174

Email

ssuzuki@med.nagoya-cu.ac.jp

Name of contact person

1st name	Hideki
Middle name
Last name	Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code

541-0042

Address

3-1-2F Kyomachibori Nishi-ku 2-chome Osaka 550-0003, Japan

TEL

06-6445-5585

Homepage URL

Email

cancer@gol.com

Institute

Basic and clinical researches on the development of chemopreventive drugs

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya City University Medical School

Address

Mizuho-ku, Nagoya 467-8601

Tel

052-853-8174

Email

tokudome@med.nagoya-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

05

Month

02

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24488498

Number of participants that the trial has enrolled

Results

Gut. 2014 Jan 31. doi: 10.1136/gutjnl-2013-305827. [Epub ahead of print]

The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial.

Ishikawa H1, Mutoh M, Suzuki S, Tokudome S, Saida Y, Abe T, Okamura S, Tajika M, Joh T, Tanaka S, Kudo SE, Matsuda T, Iimuro M, Yukawa T, Takayama T, Sato Y, Lee K, Kitamura S, Mizuno M, Sano Y, Gondo N, Sugimoto K, Kusunoki M, Goto C, Matsuura N, Sakai T, Wakabayashi K.

OBJECTIVE:
To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy.

DESIGN:
A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted.

PARTICIPANTS:
311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009.

RESULTS:
The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group.

CONCLUSIONS:
Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries.

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

Recruitment status

Main results already published

Date of protocol fixation

2006

Year

06

Month

13

Day

Date of IRB

2006

Year

06

Month

13

Day

Anticipated trial start date

2007

Year

01

Month

01

Day

Last follow-up date

2013

Year

07

Month

01

Day

Date of closure to data entry

2013

Year

09

Month

01

Day

Date trial data considered complete

2013

Year

10

Month

01

Day

Date analysis concluded

2013

Year

12

Month

01

Day

Other related information

Registered date

2007

Year

05

Month

01

Day

Last modified on

2019

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000834