Aspirin in Treating Patients With Dukes Stage C Colon or Rectal Cancer, Dukes Stage B Rectal Cancer, or High-Risk Dukes Stage B Colon Cancer That Has Been Completely Removed by Surgery - Full Text View

Sponsored by:	National Cancer Centre, Singapore
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00565708

Purpose

RATIONALE: Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The use of aspirin may slow disease progression after surgery. It is not yet known whether aspirin is more effective than a placebo in treating colorectal cancer that has been completely removed by surgery.

PURPOSE: This randomized phase III trial is studying aspirin to see how well it works compared with a placebo in treating patients with Dukes stage C colon or rectal cancer, high-risk Dukes stage B colon cancer, or Dukes stage B rectal cancer that has been completely removed by surgery.

Condition	Intervention	Phase
Colorectal Cancer	Drug: acetylsalicylic acid Procedure: adjuvant therapy	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Aspirin for Dukes C and High Risk Dukes B Colon Cancer - An International, Multi-Centre, Double Blind, Randomised Placebo Controlled Phase III Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival of all patients [ Designated as safety issue: No ]
Disease-free survival of subgroups of patients with Dukes stage C or high-risk Dukes stage B colon cancer [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival at 5 years [ Designated as safety issue: No ]
Disease-free and overall survival of Chinese, Malay, Indian, and other ethnic groups [ Designated as safety issue: No ]
Disease-free and overall survival of resected high-risk Dukes stage B colon cancer and Dukes stage C colon and rectal cancer individually [ Designated as safety issue: No ]
Disease-free and overall survival in compliant versus noncompliant patients [ Designated as safety issue: No ]

Estimated Enrollment:	2660
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Disease-free survival of patients with completely resected Dukes stage C colon or rectal cancer, Dukes stage B rectal cancer, or high-risk Dukes stage B colon cancer treated with acetylsalicylic acid (aspirin) vs placebo.
Disease-free survival of patients with Dukes stage C colon cancer or high-risk Dukes stage B colon cancer.

Secondary

Overall survival at 5 years in patients treated with these drugs.

OUTLINE: This is a multicenter study. Patients are stratified according to study site, tumor type (Dukes stage C colon cancer vs Dukes stage C rectal cancer vs Dukes stage B rectal cancer vs high-risk Dukes stage B colon cancer), and type of exposure to adjuvant oxaliplatin-based chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral acetylsalicylic acid (aspirin) once daily for up to 3 years in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive oral placebo once daily for up to 3 years in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 2 years.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of Dukes stage C colon or rectal cancer, Dukes stage B rectal cancer, or high-risk Dukes stage B colon cancer meeting the following criteria:
- Completely resected primary tumor
- Completed at least 3 months of standard therapy (chemotherapy with or without radiotherapy)
- Must be within 3 months of completion of standard therapy (surgery and chemotherapy with or without radiotherapy)
- Completed at least 3 months of adjuvant fluorouracil-based chemotherapy
Adjuvant or neoadjuvant radiotherapy allowed for rectal cancers
No familial adenomatous polyposis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine clearance > 50 mL/min
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST/ALT ≤ 3 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No uncontrolled hypertension (i.e., untreated systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 95 mm Hg)
No unexplained rise in CEA (i.e., smoker with elevated CEA will not be excluded)
No inflammatory bowel disease or ulcerative colitis
No active gastritis or peptic ulcer
No gastrointestinal bleeding within the past year
No hemorrhagic diathesis (i.e., hemophilia)
No history of erosive GERD or active erosive GERD on gastroscopy
No history of recent cancers within the past 5 years, except for nonmelanoma skin cancer or basal cell or squamous cell carcinoma
No history of recent stroke, coronary arterial disease, angina, or vascular disease
No known allergy to NSAIDs or aspirin

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No continuous acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs (NSAIDs), or cyclo-oxygenase-2 inhibitors for ≥ 4 consecutive weeks in duration
No more than 1 year since prior continuous daily use of PPI
No concurrent anticoagulants (i.e., warfarin, unfractionated heparin, or low molecular weight heparin)
No other concurrent antiplatelet agents (i.e., off-study aspirin, clopidogrel, or ticlopidine)
No other concurrent anticancer treatment
No other concurrent investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565708

Locations

China
Prince of Wales Hospital	Recruiting
Hong Kong, China
Contact: Contact Person 852-636-3337
Queen Mary Hospital - Hong Kong	Recruiting
Hong Kong, China
Contact: Contact Person 852-2855-3458
India
All India Institute of Medical Sciences	Recruiting
New Delhi, India, 110029
Contact: Contact Person 91-11-2658-9490
Kidwai Memorial Institute of Oncology	Recruiting
Bangalore, India, 560029
Contact: Contact Person 91-80-264-0245
Nizam's Institute of Medical Sciences	Recruiting
Hyderabad, India, 500 082
Contact: Contact Person 91-40-2332-0332
Tata Memorial Hospital	Recruiting
Mumbai, India, 400012
Contact: Contact Person 91-22-2417-7216
Indonesia
Cipto Mangunkusumo Hospital	Recruiting
Jakarta, Indonesia, 10430
Contact: Contact Person 82-2-2072-2390
Singapore
Johns Hopkins Singapore International Medical Centre	Recruiting
Singapore, Singapore, 119074
Contact: Contact Person 65-6880-2222
National Cancer Centre - Singapore	Recruiting
Singapore, Singapore, 169610
Contact: John Chia, MBBS, MRCP 65-96-536-990
Tan Tock Seng Hospital	Recruiting
Singapore, Singapore, 308433
Contact: Contact Person 65-6357-7807

Sponsors and Collaborators

National Cancer Centre, Singapore

Investigators

Study Chair:

John Chia, MBBS, MRCP

National Cancer Centre, Singapore

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000577892, SINGAPORE-ICR-02, SINGAPORE-ASCOLT, SINGAPORE-07-32-LGI
Study First Received:	November 29, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00565708
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Digestive System Diseases
Aspirin
Gastrointestinal Neoplasms
Colonic Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Neoplasms

Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009