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Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers (ASCOLT)

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ClinicalTrials.gov Identifier: NCT00565708
Recruitment Status : Recruiting
First Posted : November 30, 2007
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
University of Oxford
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
Information provided by (Responsible Party):
John Chia Whay Kuang, National Cancer Centre, Singapore

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)

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: placebo Drug: Acetylsalicylic acid Phase 3

Detailed 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1587 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: acetylsalicylic acid
200mg OD for 3 years
Drug: Acetylsalicylic acid
Adjuvant Therapy
Other Name: Aspirin

Placebo Comparator: Placebo
200mg OD for 3 years
Other: placebo
Placebo Comparator




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565708


Contacts
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Contact: John Chia, MBBS, MRCP 65-96536990 nmocwk@nccs.com.sg
Contact: Estelle Foo, BN,CRP estelle.foo.m.j@nccs.com.sg

  Hide Study Locations
Locations
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Australia, New South Wales
Bankstown-Lidcombe Hospital Bankstown Cancer Centre Recruiting
Bankstown, New South Wales, Australia
Contact: Ray Asghari       Ray.Asghari@sswahs.nsw.gov.au   
Principal Investigator: Ray Asghari         
Macarthur Cancer Therapy Centre Recruiting
Campbelltown, New South Wales, Australia
Contact: Lorraine Chantrill       Lorraine.chantrill@sswahs.nsw.gov.au   
Principal Investigator: Lorraine Chantrill         
Chris O'Brien Lifehouse, Clinical Research Centre Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Lisa Horvath       lisa.horvath@lh.org.au   
Principal Investigator: Lisa Horvath         
Coffs Harbour Health Campus North Coast Cancer Institute Recruiting
Coffs Harbour, New South Wales, Australia, 2450
Contact: Karen Briscoe       Kare.briscoe@ncahs.health.nsw.gov.au   
Principal Investigator: Karen Briscoe         
Central Coast Cancer Centre Gosford Hospital Recruiting
Gosford, New South Wales, Australia, 2050
Contact: Matthew Wong       Matt.wong@health.nsw.gov.au   
Principal Investigator: Matthew Wong         
Newcastle private Hospital Recruiting
New Lambton Heights, New South Wales, Australia
Contact: Anontino Bonaventura       Tony.Bonaventura@calvarymater.org.au   
Principal Investigator: Anontino Bonaventura         
Orange Health Service Recruiting
Orange, New South Wales, Australia
Contact: Robert Zielinski       Robert.zielinski@health.nsw.gov.au   
Principal Investigator: Robert Zielinski         
Port Macquarie Base Hospital North Coast Cancer Institute Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Stephen Begbie       Stephen.Begbie@ncahs.health.nsw.gov.au   
Principal Investigator: Stephen Begbie         
Northern Cancer Institute, St Leonards Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Nick Pavlakis       nick.pavlakis@sydney.edu.au   
Principal Investigator: Nick Pavlakis         
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia
Northwest Cancer Centre Tamworth Hospital Recruiting
Tamworth, New South Wales, Australia, 2340
Contact: Mathew George       Mathew.george@hnehealth.nsw.gov.au   
Principal Investigator: Mathew George         
The Tweed Hospital Recruiting
Tweed Heads, New South Wales, Australia
Contact: Ehtesham Abdi       Ehtesham.Abdi@ncahs.health.nsw.gov.au   
Principal Investigator: Ehtesham Abdi         
Calvary Mater Newcastle Hospital Recruiting
Waratah, New South Wales, Australia
Contact: James Lynam       james.lynam@calvarymater.org.au   
Principal Investigator: James Lynam         
Australia, Northern Territory
Royal Darwin Hospital Recruiting
Tiwi, Northern Territory, Australia
Contact: Narayan Karanth       Narayan.Karanth@nt.gov.au   
Principal Investigator: Narayan Karanth         
Australia, Queensland
Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Contact: Suresh Varma       Suresh.varma@health.qld.gov.au   
Principal Investigator: Suresh Varma         
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia
Contact: Melissa Eastgate       Melissa.eastgate@health.qld.gov.au   
Principal Investigator: Melissa Eastgate         
Toowoomba Hospital Recruiting
Toowoomba, Queensland, Australia
Australia, South Australia
Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Timothy Price       Timothy.Price@health.sa.gov.au   
Principal Investigator: Timothy Price         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Louise Nott       Lnott@shhs.tas.gov.au   
Principal Investigator: Louise Nott         
Australia, Victoria
Border Medical Oncology Research Unit Recruiting
Albury, Victoria, Australia
Contact: Craig Underhill       Craig.underhill@bordermedonc.com.au   
Principal Investigator: Craig Underhill         
Ballarat Regional Integrated Cancer Centre Recruiting
Ballarat, Victoria, Australia, 3350
Contact: Geoffrey Chong       Geoffreyc@bhs.org.au   
Principal Investigator: Geoffrey Chong         
Barwon Health Andrew Love Cancer Centre Recruiting
Geelong, Victoria, Australia
Contact: Mustafa Khasraw       m.khasraw@barwonhealth.org.au   
Principal Investigator: Mustafa Khasraw         
Austin Health Cancer Clinical Trials Recruiting
Heidelberg, Victoria, Australia
Contact: Niall Tebbutt       Niall.tebbutt@ludwig.edu.au   
Principal Investigator: Niall Tebbutt         
Launceston General Hospital Recruiting
Launceston, Victoria, Australia
Monash Health Medical Oncology Recruiting
Melbourne, Victoria, Australia, 3165
Contact: Andrew Strickland       ahstrickland@tpg.com.au   
Principal Investigator: Andrew Strickland         
Mildura Base Hospital Recruiting
Mildura, Victoria, Australia
Goulburn Valley Health Recruiting
Shepparton, Victoria, Australia, 3630
Contact: ZeeWan Wong       Zeewan.wong@gvhealth.org.au   
Principal Investigator: ZeeWan Wong         
St John of God Healthcare Southwest Oncology Recruiting
Warrnambool, Victoria, Australia, 3280
Contact: Theresa Hayes       thayes@swarh.vic.gov.au   
Principal Investigator: Theresa Hayes         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia
Contact: Guy van Hazel       Guy.VanHazel@health.wa.gov.au   
Principal Investigator: Guy van Hazel         
St John of God Hospital Subiaco Recruiting
Subiaco, Western Australia, Australia
Contact: Tom Van Hagen         
Principal Investigator: Tom Van Hagen         
China, Beijing
Beijing University Cancer Hospital Active, not recruiting
Beijing, Beijing, China
China, Guangdong
The First People's Hospital of Foshan City Recruiting
Foshan, Guangdong, China, 528000
Contact: Wei Wang       wangwei@fsyyy.com   
Principal Investigator: Wei Wang         
Sub-Investigator: Fen Feng         
Sixth Affiliated Hospital Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yan Hong Deng       littleqicat@163.com   
Principal Investigator: Jian Ping Wang         
Sub-Investigator: Jian Xiao         
Sub-Investigator: Yan Hong Deng         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: De Qing Wu       wdq233@139.com   
Principal Investigator: Yong Li         
Sub-Investigator: De Qing Wu         
Sun Yat Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Gong Chen       chengong@sysucc.org.cn   
Principal Investigator: Gong Chen         
Zhongshan City People's Hospital Recruiting
Zhongshan, Guangdong, China
Contact: Xiao Mei Jiang       Jiangxiaomei_007@163.com   
Principal Investigator: Jie-Wen Peng         
Sub-Investigator: Xiao Mei Jiang         
China, Shandong
Jinan Central Hospital Recruiting
Jinan, Shandong, China
Contact: Yu Ping Sun       sunyuping@live.cn   
Principal Investigator: Yu Ping Sun         
Yantai Yuhuangding Hospital Recruiting
Yantai, Shandong, China
Contact: Liang Ming Zhang       zhanglmdr@163.com   
Principal Investigator: Liang Ming Zhang         
China, Shanghai
Changhai Hospital Withdrawn
Shanghai, Shanghai, China
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Dong Xu       xudongzju@gmail.com   
Sub-Investigator: Dong Xu         
Principal Investigator: KeFeng Ding         
China
Queen Mary Hospital - Hong Kong Recruiting
Hong Kong, China
Contact: Thomas Yau         
Principal Investigator: Thomas Yau         
Sub-Investigator: Wai Lun Law         
Affiliated Hospital of Nantong University Active, not recruiting
Nantong, China
India
Kidwai Memorial Institute of Oncology Completed
Bangalore, India, 560029
Amrita Institute of Medical Sciences Withdrawn
Cochin, India
G. Kuppuswamy Naidu Memorial Hospital Recruiting
Coimbatore, India, 641 037
Contact: Sivanesan       sivanesan@jipmer.net   
Principal Investigator: Sivanesan B         
Nizam's Institute of Medical Sciences Completed
Hyderabad, India, 500 082
Tata Memorial Hospital Recruiting
Mumbai, India, 400012
Principal Investigator: Shaesta Mehta         
All India Institute of Medical Sciences Recruiting
New Delhi, India, 110029
Principal Investigator: Atul Sharma         
Regional Cancer Center Recruiting
Trivandrum, India, 695011
Contact: Sajeed       drsajeed.rcc@gmail.com   
Principal Investigator: Sajeed A         
Christian Medical College and Hospital Recruiting
Vellore, India, 632002
Contact: Raju Chacko         
Principal Investigator: Raju T Chacko         
Indonesia
Dharmais Cancer Hospital Active, not recruiting
Jakarta, Indonesia, 11420
Cipto Mangunkusumo General Hospital Completed
Jakarta, Indonesia
Rumah Sakit RSUP Dr. Sardjito Completed
Yogyakarta, Indonesia, 55284
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang-si, Gyeonggi-do, Korea, Republic of
Contact: Dae Young Zang       fhdzang@hallym.ac.kr   
Principal Investigator: Dae Young Zang         
CHA Bundang Medical centre Withdrawn
Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joong Bae Ahn         
Principal Investigator: Joong Bae Ahn         
Ajou University Hospital Recruiting
Suwon-si, Korea, Republic of
Contact: Seok Yun Kang       Kangsy01@ajou.ac.kr   
Principal Investigator: Seok Yun Kang         
Malaysia
Penang Adventist Hospital Withdrawn
George Town, Penang, Malaysia
Sarawak General Hospital Completed
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Principal Investigator: Ros Suzanna         
University of Malaysia Medical Center Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Gwo Fang Ho         
Principal Investigator: Gwo Fang Ho         
Sub-Investigator: Mastura Yusof         
University Kebangsaan Malaysia Medical Center Completed
Kuala Lumpur, Malaysia
New Zealand
Christchurch Public Hospital Recruiting
Christchurch, New Zealand, 8140
Contact: Mark Jeffrey       Mark.jeffery@cdhb.health.nz   
Principal Investigator: Mark Jeffrey         
Dunedin Hospital Recruiting
Dunedin, New Zealand
Contact: Christopher Jackson       Christopher.Jackson@southerndhb.govt.nz   
Principal Investigator: Christopher Jackson         
Philippines
Philippines General Hospital Withdrawn
Ermita, Manilla, Philippines
Saudi Arabia
King Fahad Medical City Active, not recruiting
Riyadh, Saudi Arabia, 11525
Singapore
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Chee Kian Tham       tham.c.k@nccs.com.sg   
Principal Investigator: Chee Kian Tham         
Sub-Investigator: Iain Tan         
Sub-Investigator: Su Pin Choo         
Johns Hopkins Singapore International Medical Center Completed
Singapore, Singapore
Tan Tock Seng Hospital Withdrawn
Singapore, Singapore
Sri Lanka
National Cancer Institute Recruiting
Maharagama, Sri Lanka
Contact: Asita de Silva       asita@sltnet.lk   
Principal Investigator: Mahendra Perera         
Taiwan
Shuang Ho Hospital Recruiting
Taipei, Taiwan, 23561
Principal Investigator: Tsu Yi Chao         
Koo Foundation Sun Yat Sen Cancer Centre Completed
Taipei, Taiwan
Taipei Medical University Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Po Li Wei         
Wan Fang Hospital Active, not recruiting
Taipei, Taiwan
Sponsors and Collaborators
National Cancer Centre, Singapore
University of Oxford
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
Investigators
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Study Chair: John Chia, MBBS, MRCP National Cancer Centre, Singapore
Study Chair: Raghib Ali, MBBS, MRCP University of Oxford
Study Chair: Han Chong Toh, MD, MBBS, MRCP National Cancer Centre, Singapore
Study Chair: Eva Segelov, MBBS,FRACP,PhD St. Vincent's Hospital-Manhattan

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Chia Whay Kuang, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00565708     History of Changes
Other Study ID Numbers: CDR0000577892
SINGAPORE-ICR-02 ( Other Identifier: SCRI )
SINGAPORE-ASCOLT ( Other Identifier: SCRI )
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by John Chia Whay Kuang, National Cancer Centre, Singapore:
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics