Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Colorectal Cancer Clinical Trial

— ASCOLT  

Official title:

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00565708
• Other study ID #: CDR0000577892
• Secondary ID: SINGAPORE-ICR-02
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2008
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control.

Eligible patients will be randomized to treatment arms, using the following stratification factors:

• Study Centre

• Tumour Type

• Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin

Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1587
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• placebo
Placebo Comparator

Drug:
• Acetylsalicylic acid
Adjuvant Therapy

Locations

Country	Name	City	State
Australia	Border Medical Oncology Research Unit	Albury	Victoria
Australia	Ballarat Regional Integrated Cancer Centre	Ballarat	Victoria
Australia	Bankstown-Lidcombe Hospital Bankstown Cancer Centre	Bankstown	New South Wales
Australia	Macarthur Cancer Therapy Centre	Campbelltown	New South Wales
Australia	Chris O'Brien Lifehouse, Clinical Research Centre	Camperdown	New South Wales
Australia	Coffs Harbour Health Campus North Coast Cancer Institute	Coffs Harbour	New South Wales
Australia	Townsville Hospital	Douglas	Queensland
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Barwon Health Andrew Love Cancer Centre	Geelong	Victoria
Australia	Central Coast Cancer Centre Gosford Hospital	Gosford	New South Wales
Australia	Austin Health Cancer Clinical Trials	Heidelberg	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Launceston General Hospital	Launceston	Victoria
Australia	Monash Health Medical Oncology	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Newcastle private Hospital	New Lambton Heights	New South Wales
Australia	Orange Health Service	Orange	New South Wales
Australia	Port Macquarie Base Hospital North Coast Cancer Institute	Port Macquarie	New South Wales
Australia	Goulburn Valley Health	Shepparton	Victoria
Australia	Northern Cancer Institute, St Leonards	St Leonards	New South Wales
Australia	St John of God Hospital Subiaco	Subiaco	Western Australia
Australia	St Vincent's Hospital	Sydney	New South Wales
Australia	Northwest Cancer Centre Tamworth Hospital	Tamworth	New South Wales
Australia	Royal Darwin Hospital	Tiwi	Northern Territory
Australia	Toowoomba Hospital	Toowoomba	Queensland
Australia	The Tweed Hospital	Tweed Heads	New South Wales
Australia	Calvary Mater Newcastle Hospital	Waratah	New South Wales
Australia	St John of God Healthcare Southwest Oncology	Warrnambool	Victoria
China	Beijing University Cancer Hospital	Beijing	Beijing
China	The First People's Hospital of Foshan City	Foshan	Guangdong
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Sixth Affiliated Hospital	Guangzhou	Guangdong
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Queen Mary Hospital - Hong Kong	Hong Kong
China	Jinan Central Hospital	Jinan	Shandong
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Koo Foundation Sun Yat Sen Cancer Centre	Taibei	Taiwan
China	Shuang Ho Hospital	Taibei	Taiwan
China	Taipei Medical University Hospital	Taibei	Taiwan
China	Wan Fang Hospital	Taibei	Taiwan
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Zhongshan City People's Hospital	Zhongshan	Guangdong
India	Kidwai Memorial Institute of Oncology	Bangalore
India	G. Kuppuswamy Naidu Memorial Hospital	Coimbatore
India	Nizam's Institute of Medical Sciences	Hyderabad
India	Tata Memorial Hospital	Mumbai
India	All India Institute of Medical Sciences	New Delhi
India	Regional Cancer Center	Trivandrum
India	Christian Medical College and Hospital	Vellore
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta
Indonesia	Dharmais Cancer Hospital	Jakarta
Indonesia	Rumah Sakit RSUP Dr. Sardjito	Yogyakarta
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Severance Hospital	Seoul
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University Kebangsaan Malaysia Medical Center	Kuala Lumpur
Malaysia	University of Malaysia Medical Center	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching	Sarawak
New Zealand	Christchurch Public Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
Saudi Arabia	King Fahad Medical City	Riyadh
Singapore	Johns Hopkins Singapore International Medical Center	Singapore
Singapore	National Cancer Centre - Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Sri Lanka	National Cancer Institute	Maharagama

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Australasian Gastro-Intestinal Trials Group, INDOX Cancer Research Network, University of Sydney

Countries where clinical trial is conducted

Australia,  China,  India,  Indonesia,  Korea, Republic of,  Malaysia,  New Zealand,  Saudi Arabia,  Singapore,  Sri Lanka, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Recurrence data documented	5 years
Secondary	Overall survival	Death data documented	5 years