This study has been transitioned to CTIS with ID 2022-502324-48-00 check the CTIS register for the current data. To study the effect of 80mg aspirin (given orally once daily for five years) on fiveyear overall survival (OS) for stage II and III…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the trial is five year Overall Survival (5-yr OS).
Secondary outcome
-To study the effect of aspirin on 3 year disease free survival (DFS) in
patients with stage II and III colon cancer.
-To study the effect of aspirin on time to treatment failure (TTF).
-To study the effect of aspirin on toxicity, for example the interaction of
aspirin with chemotherapy.
Background summary
Colon cancer is one of the most common cancer types in developed country's. In
Europe, colorectal cancer is the second cause of cancer death. Recent studies
show that the use of aspirin after the diagnosis of colon cancer has a
significant survival benefit. Chan et al. found a 30% mortality reduction in
patients using aspirin (JAMA 2009;302(6):649-58). The studies done so far were
all retrospective cohort analysis. A limitation in these studies is confounding
by indication.
Therefore, there is a great need for a randomised trial, mainly when there is a
chance for micrometastasis (stage II and III colon cancer). This could lead to
a new treatment option after surgery without much side effects and with
relatively low costs.
Study objective
This study has been transitioned to CTIS with ID 2022-502324-48-00 check the CTIS register for the current data.
To study the effect of 80mg aspirin (given orally once daily for five years) on
fiveyear overall survival (OS) for stage II and III colon cancer patients
Study design
A phase III doubleblind placebo controlled,randomized trial of adjuvant
low-dose aspirin in colon cancer patients.
Patients will be stratified according to:
-Stage (II or III)
-Age (<70/>=70 years)
Intervention
Patients will be randomized for aspirin 80 mg po daily for 5 years versus
placebo within 12 weeks after curative resection of the tumour. Aspirin 80 mg
or placebo will be used every day for the duration of five years. Followup will
be regarding the national guidelines (www.oncoline.nl). There will be no
different interventions in the scope of this trial.
Study burden and risks
Most important risk in aspirin use is gastro-intestinal bleeding. Given the
widespread use of low dose aspirin in cardiovascular risk management, it is
unlikely that new toxicities will be identified. When identified, this will be
registered. Every patient will be followed up during five years. During every
clinical visit, side-effects of aspirin will be monitored.
Impact, burden and risks for the patients in experimental and placebo-arm:
When randomised for aspirin treatment, patient will use one tablet of aspirin
daily during five years.The risk for the patient and the possible side effects
that can occur are described above. The followup is not different from the
regular followup for patients with colon cancer.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
• Patients 45 years and older
• Patients 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) (in case of >1 tumour: more
advanced tumour is stage II or III) (TNM version 7)
• Patients who have undergone curative radical resection (R0 resection) within
12 weeks prior to study entry
• Written informed consent according to national and local regulation
Exclusion criteria
• Patients with rectal cancer (defined as tumour within 15 cm from the anal
verge)
• Patients currently taking (low-dose) acetylsalicylic acid or other
anti-aggregantia for any reason
• Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs
• 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 or equivalent)
• 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
(father/mother/brother/sister/son/daughter)
• Allergy or intolerance to salicylates
• Patients with local or distant recurrent disease
• Previous malignancies other than CIN, BCC or SCC with a disease free survival
less than 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-502324-48-00 |
| EudraCT | EUCTR2011-004686-32-NL |
| CCMO | NL38132.058.14 |