A Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Antwerp University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

31 Jul 2017 → ongoing

Decision date (initial)

2023-03-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Kom op tegen Kanker · Anticancer Fund

External identifiers

EU CT number

2022-502798-40-00

EudraCT number

2017-001397-41

ClinicalTrials.gov

NCT03464305

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To study 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

Secondary objectives 3

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

Conditions and MedDRA coding

Patients with resected colon carcinoma

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients 45 years and older
2. Patients with histologically confirmed adenocarcinoma of the colon
3. 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: more advanced tumour is stage II or III)
4. Patients who have undergone curative radical resection (R0 resection) within 12 weeks prior to study entry
5. Written informed consent according to national and local regulation

Exclusion criteria 11

1. Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
2. Patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia for any reason
3. Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs
4. Patients with a history of bleeding disorders or active gastric or duodenal ulcers
5. Patients currently taking high dose systemic glucocorticoids. (≥ 30 mg predniso(lo)n or equivalent)
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 (father/mother/brother/sister/son/daughter)
8. Allergy or intolerance to salicylates
9. Patients with local or distant recurrent disease
10. Previous malignancies other than CIN, BCC or SCC with a disease free survival less than 5 years
11. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is 5 year Overall Survival (5y-OS). The time to an event for OS is defined as the time interval between the date of randomisation and the date of death. A patient that is still alive at the last date of follow-up patient is censored for analysis and the time at risk corresponds to the time interval between the date of randomisation and the date of last follow up.

Secondary endpoints 2

1. Disease Free Survival (DFS). The time to an event for DFS is defined as the time interval between the date of randomisation and the date of disease recurrence or death, whichever comes first. Recurrence of a disease can be a loco-regional recurrence, a distant recurrence or a new primary colon cancer. The evidence for recurrence must be documented in the patients’ file. The date of radiological evidence, e.g. CT, MRI, etc, or colonoscopy will be considered as date of recurrence.
2. Time to Treatment Failure (TTF). The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antwerp University Hospital

Sponsor organisation

Antwerp University Hospital

Address

Drie Eikenstraat 655

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

Antwerp University Hospital

Contact name

Study coordinator

Public contact point

Organisation

Antwerp University Hospital

Contact name

Study coordinator

Locations

1 EU/EEA country · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications