Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overOtherCDR0000577892
SINGAPORE-ICR-02, SINGAPORE-ASCOLT, SINGAPORE-07-32-LGI, ICR-02, NCT00565708

Trial Description

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)

Further Study Information

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

Eligibility 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Centre - Singapore

  • Oxford Radcliffe Hospital
  • Australasian Gastro-Intestinal Trials Group
  • INDOX Cancer Research Network
John Chia, Study Chair
Raghib Ali, MBBS, MRCP, Study Chair
Han Chong Toh, MD, MBBS, MRCP, Study Chair
Eva Segelov, MBBS,FRACP,PhD, Study Chair
John Chia, MBBS, MRCP
Ph: 65-96536990
Email: nmocwk@nccs.com.sg

Trial Sites

Australia

Nedlands

Sir Charles Gairdner Hospital - Nedlands

Guy Van Hazel
Email: Guy.VanHazel@health.wa.gov.au

Guy van Hazel
Principal Investigator

Subiaco

St John of God Hospital Subiaco

David Ransom
Email: dtransom@iinet.net.au

David Ransom
Principal Investigator

New South Wales
Bankstown

Bankstown-Lidcombe Hospital Bankstown Cancer Centre

Ray Asghari
Email: Ray.Asghari@sswahs.nsw.gov.au

Ray Asghari
Principal Investigator

Campbelltown

Macarthur Cancer Therapy Centre

Lorraine Chantrill
Email: Lorraine.chantrill@sswahs.nsw.gov.au

Lorraine Chantrill
Principal Investigator

New Lambton Heights

Newcastle private Hospital

Anontino Bonaventura
Email: Tony.Bonaventura@calvarymater.org.au

Anontino Bonaventura
Principal Investigator

Orange

Orange Health Service

Robert Zielinski
Email: Robert.zielinski@health.nsw.gov.au

Robert Zielinski
Principal Investigator

Port Macquarie

Port Macquarie Base Hospital North Coast Cancer Institute

Stephen Begbie
Email: Stephen.Begbie@ncahs.health.nsw.gov.au

Stephen Begbie
Principal Investigator

Waratah

Calvary Mater Newcastle Hospital

Fiona Day
Email: Fiona.Day@calvarymater.org.au

Fiona Day
Principal Investigator

Queensland
Herston

Royal Brisbane and Women's Hospital

Melissa Eastgate
Email: Melissa.eastgate@health.qld.gov.au

Melissa Eastgate
Principal Investigator

Tasmania
Hobart

Royal Hobart Hospital

Louise Nott
Email: Lnott@shhs.tas.gov.au

Louise Nott
Principal Investigator

China

Beijing

Beijing University Cancer Hospital

Xi Cheng Wang
Email: xicheng.wang@gmail.com

Shen Lin
Principal Investigator

Xi Chen Wang
Sub-Investigator

Foshan

First People’s Hospital of Foshan

Wei Wang
Email: wangwei@fsyyy.com

Wei Wang
Principal Investigator

Fen Feng
Sub-Investigator

Guangzhou

Sixth Affiliated Hospital

Yan Hong Deng
Email: littleqicat@163.com

Jian Ping Wang
Principal Investigator

Jian Xiao
Sub-Investigator

Yan Hong Deng
Sub-Investigator

Sun Yat Sen University Cancer Center

Gong Chen
Email: chengong@sysucc.org.cn

Gong Chen
Principal Investigator

Hangzhou

The Second Affiliated Hospital of Zhejiang University

Dong Xu
Email: xudongzju@gmail.com

Dong Xu
Sub-Investigator

KeFeng Ding
Principal Investigator

Hong Kong

Queen Mary Hospital - Hong Kong

Thomas Yau

Thomas Yau
Principal Investigator

Wai Lun Law
Sub-Investigator

Zhongshan

Zhongshan City People's Hospital

Xiao Mei Jiang
Email: Jiangxiaomei_007@163.com

Jie-Wen Peng
Principal Investigator

Xiao Mei Jiang
Sub-Investigator

India

Bangalore

Kidwai Memorial Institute of Oncology

Loknatha Dasappa
Principal Investigator

Coimbatore

G. Kuppuswamy Naidu Memorial Hospital

Contact Person
Ph: 91-422-227-1452

Sivanesan B
Principal Investigator

Hyderabad

Nizam's Institute of Medical Sciences

G Sadashivudu
Principal Investigator

Mumbai

Tata Memorial Hospital

Shaesta Mehta
Principal Investigator

New Delhi

All India Institute of Medical Sciences

Atul Sharma
Principal Investigator

Trivandrum

Regional Cancer Center

Contact Person
Ph: 91-471-244-2541

Sajeed A
Principal Investigator

Vellore

Christian Medical College and Hospital

Raju Chacko

Raju T Chacko
Principal Investigator

Indonesia

Jakarta

Dharmais Cancer Hospital

Ajodei Soemardi
Principal Investigator

Syafrizal Syafei
Sub-Investigator

Yogyakarta

Rumah Sakit RSUP Dr. Sardjito

Johan Kurnianda
Principal Investigator

Malaysia

Kuala Lumpur

Hospital Kuala Lumpur

Ros Suzanna
Principal Investigator

University Kebangsaan Malaysia Medical Center

Voon Fong Kua

Voon Fong Kua
Principal Investigator

University of Malaysia Medical Center

Gwo Fang Ho

Gwo Fang Ho
Principal Investigator

Mastura Yusof
Sub-Investigator

Sarawak

Sarawak General Hospital

Beena Devi
Principal Investigator

New Zealand

Christchurch

Christchurch Public Hospital

Mark Jeffrey
Email: Mark.jeffery@cdhb.health.nz

Mark Jeffrey
Principal Investigator

Republic of Korea

Seoul

Severance Hospital

Joong Bae Ahn

Joong Bae Ahn
Principal Investigator

Republic of Singapore

Singapore

National Cancer Centre - Singapore

Chee Kian Tham
Email: tham.c.k@nccs.com.sg

Chee Kian Tham
Principal Investigator

Iain Tan
Sub-Investigator

Su Pin Choo
Sub-Investigator

Saudi Arabia

Riyadh

King Fahad Hospital

Abdullah Al Sharm
Principal Investigator

Sri Lanka

Maharagama

National Cancer Institute

Asita de Silva
Email: asita@sltnet.lk

Mahendra Perera
Principal Investigator

Taiwan

Taipei

Shuang Ho Hospital

Tsu Yi Chao
Principal Investigator

Sun Yat-Sen Cancer Center Taiwan

I-Ping Huang
Email: iphuang@kfsyscc.org

I-Ping Huang
Principal Investigator

Hung Chen Cheng
Sub-Investigator

Taipei Medical University Hospital

Po Li Wei
Principal Investigator

Wan Fang Hospital

Gi Ming Lai
Email: gminlai@nhri.org.tw

Gi Ming Lai
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00565708
ClinicalTrials.gov processed this data on February 18, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.