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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00565708




Registration number
NCT00565708
Ethics application status
Date submitted
29/11/2007
Date registered
30/11/2007
Date last updated
2/02/2024

Titles & IDs
Public title
Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
Scientific title
Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
Secondary ID [1] 0 0
SINGAPORE-ICR-02
Secondary ID [2] 0 0
CDR0000577892
Universal Trial Number (UTN)
Trial acronym
ASCOLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - placebo
Treatment: Drugs - Acetylsalicylic acid

Experimental: acetylsalicylic acid - 200mg OD for 3 years

Placebo Comparator: Placebo - 200mg OD for 3 years


Other interventions: placebo
Placebo Comparator

Treatment: Drugs: Acetylsalicylic acid
Adjuvant Therapy
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Male or female outpatient of = 18 years of age or = country's legal age for adult
consent

- Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C
rectal cancer (see Appendix 1 for definition of High Risk Dukes B)

- Undergone complete resection of primary tumour

- Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )

- Within 120 days of completion of standard therapy (surgery, chemotherapy ±
radiotherapy)

- ECOG performance status 0 to 2

- Satisfactory haematological or biochemical functions (tests should be carried out
within 8 weeks prior to randomisation): Results of clinical investigations carried out
within 8 weeks prior to randomisation can be used in place of the required screening
investigations. Patients with mild laboratory abnormalities can be included at the
discretion by the site principal investigator, and after approval by ASCOLT Trial
Management Group

- ANC = 1.0 x 109/L

- Platelets = 100 x 109/L

- Creatinine clearance = 30 mL/min

- Total bilirubin = 2.0 x the upper limit normal

- AST & ALT = 5 x the upper limit normal

- Completed the following investigations

- Colonoscopy(or CT colonogram(within 16 months prior to randomization)

- Imaging of abdomen (CT or CT colonogram or MRI or PET or Ultrasound) within 16 months
prior to randomization

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative
colitis

- Active gastritis or active peptic ulcer

- History of continuous daily use of PPI more than 1 year prior to consent

- Gastrointestinal bleeding within the past one year

- Haemorrhagic diathesis (i.e. haemophilia)

- Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic
blood pressure > 95 mmHg)

- History of recent cancers (except for colorectal cancers, non-melanoma skin cancers,
basal cell carcinomas, squamous cell carcinomas) in the past 5 years

- History of stroke, coronary arterial disease, angina, or vascular disease

- Patients who are on current long term treatment (= 4 consecutive weeks) with Aspirin,
NSAID or Cox-2 inhibitors

- History of erosive GERD or active erosive GERD on gastroscopy.

- Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin,
clopidogrel, ticlopidine)

- Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular
weight heparins)

- Pregnant, lactating, or not using adequate contraception

- Patient having known allergy to NSAID or Aspirin

- Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded)

- Patient on other investigational drug

- Patients with HNPCC (Lynch Syndrome)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
1587
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital Bankstown Cancer Centre - Bankstown
Recruitment hospital [2] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [3] 0 0
Chris O'Brien Lifehouse, Clinical Research Centre - Camperdown
Recruitment hospital [4] 0 0
Coffs Harbour Health Campus North Coast Cancer Institute - Coffs Harbour
Recruitment hospital [5] 0 0
Central Coast Cancer Centre Gosford Hospital - Gosford
Recruitment hospital [6] 0 0
Newcastle private Hospital - New Lambton Heights
Recruitment hospital [7] 0 0
Orange Health Service - Orange
Recruitment hospital [8] 0 0
Port Macquarie Base Hospital North Coast Cancer Institute - Port Macquarie
Recruitment hospital [9] 0 0
Northern Cancer Institute, St Leonards - St Leonards
Recruitment hospital [10] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [11] 0 0
Northwest Cancer Centre Tamworth Hospital - Tamworth
Recruitment hospital [12] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [13] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [14] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [15] 0 0
Townsville Hospital - Douglas
Recruitment hospital [16] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [17] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [18] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [19] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [20] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [21] 0 0
Ballarat Regional Integrated Cancer Centre - Ballarat
Recruitment hospital [22] 0 0
Barwon Health Andrew Love Cancer Centre - Geelong
Recruitment hospital [23] 0 0
Austin Health Cancer Clinical Trials - Heidelberg
Recruitment hospital [24] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [25] 0 0
Monash Health Medical Oncology - Melbourne
Recruitment hospital [26] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [27] 0 0
St John of God Healthcare Southwest Oncology - Warrnambool
Recruitment hospital [28] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [29] 0 0
St John of God Hospital Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2050 - Gosford
Recruitment postcode(s) [6] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [7] 0 0
- Orange
Recruitment postcode(s) [8] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [9] 0 0
2065 - St Leonards
Recruitment postcode(s) [10] 0 0
- Sydney
Recruitment postcode(s) [11] 0 0
2340 - Tamworth
Recruitment postcode(s) [12] 0 0
- Tweed Heads
Recruitment postcode(s) [13] 0 0
- Waratah
Recruitment postcode(s) [14] 0 0
- Tiwi
Recruitment postcode(s) [15] 0 0
4814 - Douglas
Recruitment postcode(s) [16] 0 0
- Herston
Recruitment postcode(s) [17] 0 0
- Toowoomba
Recruitment postcode(s) [18] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [19] 0 0
7000 - Hobart
Recruitment postcode(s) [20] 0 0
- Albury
Recruitment postcode(s) [21] 0 0
3350 - Ballarat
Recruitment postcode(s) [22] 0 0
- Geelong
Recruitment postcode(s) [23] 0 0
- Heidelberg
Recruitment postcode(s) [24] 0 0
- Launceston
Recruitment postcode(s) [25] 0 0
3165 - Melbourne
Recruitment postcode(s) [26] 0 0
3630 - Shepparton
Recruitment postcode(s) [27] 0 0
3280 - Warrnambool
Recruitment postcode(s) [28] 0 0
- Nedlands
Recruitment postcode(s) [29] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Jiangsu
Country [4] 0 0
China
State/province [4] 0 0
Shandong
Country [5] 0 0
China
State/province [5] 0 0
Taiwan
Country [6] 0 0
China
State/province [6] 0 0
Zhejiang
Country [7] 0 0
China
State/province [7] 0 0
Hong Kong
Country [8] 0 0
India
State/province [8] 0 0
Bangalore
Country [9] 0 0
India
State/province [9] 0 0
Coimbatore
Country [10] 0 0
India
State/province [10] 0 0
Hyderabad
Country [11] 0 0
India
State/province [11] 0 0
Mumbai
Country [12] 0 0
India
State/province [12] 0 0
New Delhi
Country [13] 0 0
India
State/province [13] 0 0
Trivandrum
Country [14] 0 0
India
State/province [14] 0 0
Vellore
Country [15] 0 0
Indonesia
State/province [15] 0 0
Jakarta
Country [16] 0 0
Indonesia
State/province [16] 0 0
Yogyakarta
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeonggi-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Malaysia
State/province [19] 0 0
Sarawak
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
New Zealand
State/province [21] 0 0
Christchurch
Country [22] 0 0
New Zealand
State/province [22] 0 0
Dunedin
Country [23] 0 0
Saudi Arabia
State/province [23] 0 0
Riyadh
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
Sri Lanka
State/province [25] 0 0
Maharagama

Funding & Sponsors
Primary sponsor type
Other
Name
National Cancer Centre, Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Gastro-Intestinal Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
INDOX Cancer Research Network
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in
patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in
this patient population over placebo control. If indeed found to be beneficial, because
aspirin is cheap and easy to administer, it will positively impact the lives of many
individuals in Asia and globally.

STUDY OBJECTIVE

To assess the effectiveness of Aspirin against placebo control in patients with dukes C or
high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall
Survival (OS)

Primary endpoints

- DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer
and rectal cancer patient sub-groups);

- DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).

Secondary endpoints

- Overall survival (OS) over 5 years

- DFS and OS in

- Chinese, Malay, Indian and other ethnic groups

- Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer
sub-groups, individually

- Compliant versus non-compliant subjects

- PIK3CA mutated tumors (where samples are available)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00565708
Trial related presentations / publications
Segelov E, Prenen H, Day D, Macintyre CR, Foo EMJ, Ali R, Wang Q, Wei X, Lopes GL Jr, Ding K, Chen G, Chia JWK, Toh HC; ASCOLT Investigators. Impact of the COVID-19 Epidemic on a Pan-Asian Academic Oncology Clinical Trial. JCO Glob Oncol. 2020 Apr;6:585-588. doi: 10.1200/GO.20.00072. No abstract available.
Day D, Toh HC, Ali R, Foo EMJ, Simes J, Chia JWK, Segelov E; ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Glob Oncol. 2023 Jun;9:e2300040. doi: 10.1200/GO.23.00040.
Public notes

Contacts
Principal investigator
Name 0 0
John Chia, MBBS, MRCP
Address 0 0
National Cancer Centre, Singapore
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00565708