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Aspirin Trial


- candidate number12151
- NTR NumberNTR3370
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2012
- Secondary IDs2011-004686-32 EudraCT
- Public TitleAspirin Trial
- Scientific TitleA Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
- ACRONYM
- hypothesisPreclinical, epidemiologic and clinical evidence suggest that aspirin use may reduce overall cancer risk and mortality in colon cancer patients.
- Healt Condition(s) or Problem(s) studiedColon cancer, Older adults, Aspirin, Survival
- Inclusion criteriaPatients with histologically confirmed adenocarcinoma of the colon Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) Patients who have undergone curative radical resection (R0 resection) within 8 weeks prior to study entry Age ≥70 years Before patient randomization, written informed consent must be given according to national and local regulation
- Exclusion criteria Patients with rectal cancer (defined as tumor within 15 cm from the anal verge). Patients currently taking (low-dose) aspirin for any reason. Patients currently taking oral coagulants. Patients with a history of bleeding disorders or active gastric or duodenal ulcers. Allergy or intolerance to salicylates. Patients with local or distant recurrent disease. Previous malignancies other than CIN or SSC in the last 5 years Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2022
- Target number of participants1588
- InterventionsAspirin 80 mg once daily during 5 years or placebo after surgery.
Follow-up of the colon cancer according to national guidelines, no additional visits or interventions besides aspirin or placebo.
- Primary outcomeTo study effect of 80mg aspirin (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 70 years of age and older.
- Secondary outcome1. To study the effect of aspirin on 3 year disease free survival (DFS) in patients 70 years of age or older with stage II and III colon cancer;
2. To study the effect of aspirin on time to treatment failure (TTF);
3. To study the effect of aspirin on toxicity, for example the interaction of aspirin with chemotherapy.
- Timepoints1. Inclusion: 3 years;
2. Follow-up 5 years;
3. Total years: 8.
- Trial web sitewww.aspirinagainstcancer.org
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Datacenter Heelkunde
- CONTACT for SCIENTIFIC QUERIES Datacenter Heelkunde
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars, Nuts/Ohra
- Publications
- Brief summaryRationale: Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients.

Objective: To investigate acetylsalicylic acid 80 mg po daily for 5 years as an adjuvant therapy in curatively operated, stage II and III colon cancer patients.

Study design: A phase III double-blind placebo-controlled randomised trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. The question will be addressed by means of two parallel studies in patients treated with or without adjuvant chemotherapy.

Inclusion criteria
1. Histologically confirmed adenocarcinoma of the colon
2. TNM stage: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
3. Age ≥ 45 years
4. Completed surgical resection (R0) within 12 weeks of randomisation
5. Written informed consent according to local Ethics Committee requirements

Exclusion criteria
1. Rectal cancer (defined as tumor within 15 cm from the anal verge)
2. Currently taking oral anti-coagulants.
3. Currently taking (low-dose) aspirin for any reason
4. History of bleeding disorders or active gastric or duodenal ulcers
5. Currently taking high dose (≥ 30 mg predniso(lo)ne) systemic glucocorticoids
6. Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
7. Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
8. Local or distant recurrent disease
9. Allergy or intolerance for salicylates
10. History of other malignancies in the last 5 years, except for SSC, BCC or CIN
11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Intervention: Patients will be randomised for acetylsalicylic acid 80 mg po daily for 5 years versus placebo.

Main study parameters/endpoints: The primary endpoint of the trial is 5 year Overall Survival (5-yr OS). Secondary endpoints are Time to Treatment Failure (TTF; time elapsed between randomisation until treatment discontinuation due to disease recurrence, unacceptable toxicity, death or any other event of interest) and 3-year Disease Free Survival (DFS); time to recurrence or death due to any cause. The trial is powered to identify a hazard ratio of 0.75 in the acetylsalicylic acid arm, with 80 percent power and a type 1 error of 0.05 (2-sided). In order for the trial to be successful, 1588 patients need to be randomised.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Unexpected adverse events may occur. Given the widespread use of low dose acetylsalicylic acid in cardiovascular risk management, it is unlikely that new toxicities will be identified. However, adverse anti-cancer effects may be identified. An independent data safety monitoring board will oversee trial conduct. A planned interim futility analysis allows early termination of the study if it appears that acetylsalicylic acid will not favourably impact colon cancer outcome.
- Main changes (audit trail)27-nov-2016: NEW:

Inclusion criteria
1. Histologically confirmed adenocarcinoma of the colon
2. TNM stage: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
3. Age ≥ 45 years
4. Completed surgical resection (R0) within 12 weeks of randomisation
5. Written informed consent according to local Ethics Committee requirements

Exclusion criteria
1. Rectal cancer (defined as tumor within 15 cm from the anal verge)
2. Currently taking oral anti-coagulants.
3. Currently taking (low-dose) aspirin for any reason
4. History of bleeding disorders or active gastric or duodenal ulcers
5. Currently taking high dose (≥ 30 mg predniso(lo)ne) systemic glucocorticoids
6. Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
7. Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
8. Local or distant recurrent disease
9. Allergy or intolerance for salicylates
10. History of other malignancies in the last 5 years, except for SSC, BCC or CIN
11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Primary outcome
To study effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients.

Secondary outcome
1. To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS)
2. To study the effect of acetylsalicylic acid on time to treatment failure (TTF)
3. To study the effect of acetylsalicylic acid on toxicity, for example the interaction of acetylsalicylic acid with chemotherapy.
- RECORD27-mrt-2012 - 7-feb-2017


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