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Clinical Trials (PDQ®)

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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

John ChiaStudy Chair

Raghib Ali, MBBS, MRCPStudy Chair

Toh Han ChongStudy Chair

John ChiaPh: 65-96536990
  Email: nmocwk@nccs.com.sg

Trial Sites

China
  Beijing
 Beijing University Cancer Hospital
 Shen LinPrincipal Investigator
  Foshan
 First People’s Hospital of Foshan
 Wang WeiPrincipal Investigator
  Guangzhou
 Sixth Affiliated Hospital
 Wang Jian PingPrincipal Investigator
 Xiao JianSub-Investigator
 Deng Yan HongSub-Investigator
 Sun Yat-Sen University Cancer Center
 Chen GongPrincipal Investigator
  Hangzhou
 The Second Affiliated Hospital of Zhejiang University
 Xu DongPrincipal Investigator
  Hong Kong
 Queen Mary Hospital - Hong Kong
 Thomas YauPrincipal Investigator
 Law Wai LunSub-Investigator
  Zhongshan
 Zhongshan City People's Hospital
 Peng Jie-WenPrincipal Investigator
India
  Bangalore
 Kidwai Memorial Institute of Oncology
 Loknatha DasappaPrincipal Investigator
  Coimbatore
 G. Kuppuswamy Naidu Memorial Hospital
 Contact Person Ph: 91-422-227-1452
 Sivanesan BPrincipal Investigator
  Hyderabad
 Nizam's Institute of Medical Sciences
 G SadashivuduPrincipal Investigator
  Mumbai
 Tata Memorial Hospital
 Shaesta MehtaPrincipal Investigator
  New Delhi
 All India Institute of Medical Sciences
 Atul SharmaPrincipal Investigator
  Trivandrum
 Regional Cancer Center
 Contact Person Ph: 91-471-244-2541
 Sajeed APrincipal Investigator
  Vellore
 Christian Medical College and Hospital
 Raju Titus ChackoPrincipal Investigator
Indonesia
  Jakarta
 Dharmais Cancer Hospital
 Ajodei SoemardiPrincipal Investigator
 Syafrizal SyafeiSub-Investigator
  Yogyakarta
 Rumah Sakit RSUP Dr. Sardjito
 Johan KurniandaPrincipal Investigator
Malaysia
  Kuala Lumpur
 Hospital Kuala Lumpur
 Ros SuzannaPrincipal Investigator
 University Kebangsaan Malaysia Medical Center
 Kua Voon FongPrincipal Investigator
 University of Malaysia Medical Center
 Ho Gwo FuangPrincipal Investigator
 Mastura YusofSub-Investigator
  Sarawak
 Sarawak General Hospital
 Beena DeviPrincipal Investigator
Republic of Korea
  Seoul
 Severance Hospital
 Jae Kyung RohPrincipal Investigator
 Joong Bae AhnSub-Investigator
Republic of Singapore
  Singapore
 National Cancer Centre - Singapore
 Tham Chee KianPrincipal Investigator
 Lim Hwee YongSub-Investigator
 Iain TanSub-Investigator
 Choo Su PinSub-Investigator
Saudi Arabia
  Riyadh
 King Fahad Hospital
 Abdullah Al SharmPrincipal Investigator
Sri Lanka
  Maharagama
 National Cancer Institute
 Asita de Silva
  Email: asita@sltnet.lk
 Mahendra PereraPrincipal Investigator
Taiwan
  Taipei
 Shuang Ho Hospital
 Tsu Yi ChaoPrincipal Investigator
 Sun Yat-Sen Cancer Center Taiwan
 I Ping HuangPrincipal Investigator
 Hung Chen ChengSub-Investigator
 Taipei Medical University Hospital
 Po Li WeiPrincipal Investigator
 Wan Fang Hospital
 Gi Ming LaiPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00565708
ClinicalTrials.gov processed this data on November 12, 2014

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.

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