A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Lead Sponsor: Leiden University Medical Center

Collaborator: Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Dutch Colorectal Cancer Group
Stichting Geriatrische Oncologie Nederland (GeriOnNe)
Fonds NutsOhra
Innovatiefonds Zorgverzekeraars

The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.

The purpose of this study is to determine the 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 of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

• Colon Cancer
• Adjuvant Therapy

Intervention Type: Drug

Intervention Name: Acetylsalicylic acid

Arm Group Label: Aspirin

Other Name: Aspirin

Intervention Type: Drug

Intervention Name: Placebo Acetylsalicylic acid

Arm Group Label: Placebo

Other Name: Placebo

Criteria:

Inclusion Criteria:

- Age ≥45 years

- 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) (in case of >1 tumour: largest tumour is stage II or III)

- Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation

Exclusion Criteria:

- Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)

- Patients currently taking oral anti-coagulants or use of LMWH

- Patients currently taking acetylsalicylic acid for any reason

- Patients with a history of bleeding disorders or active gastric or duodenal ulcers

- Patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n)

- Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)

- Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member

- Allergy or intolerance to salicylates.

- Patients with a history of other malignancies in the last 5 years, except for SCC or CIN.

- 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

Gender: All

Minimum Age: 45 Years

Maximum Age: N/A

Healthy Volunteers: No

Last Name: J.P.B.M. Braak

Phone: 0031715263500

Email: [email protected]

Netherlands

February 2020

Type: Principal Investigator

Investigator Affiliation: Leiden University Medical Center

Investigator Full Name: GJLiefers

Investigator Title: Surgical Oncologist

• Acetylsalicylic acid
• Colon cancer
• Survival

• Colonic Neoplasms
• Recurrence

Label: Aspirin

Type: Experimental

Description: Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.

Label: Placebo

Type: Placebo Comparator

Description: Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)