Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,588
Countries
1
Sites
36
Patients with resected colon carcinoma
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
Key facts
- Sponsor
- Leiden University Medical Center
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Aug 2014 → ongoing
- Decision date (initial)
- 2023-02-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fonds NutsOhra · Innovatiefonds Zorgverzekeraars
External identifiers
- EU CT number
- 2022-502324-48-00
- EudraCT number
- 2011-004686-32
- ClinicalTrials.gov
- NCT02301286
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
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 objectives 3
- To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS)
- To study the effect of acetylsalicylic acid on time to treatment failure (TTF)
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10009954 | Colon cancer stage II | 100000004864 |
| 21.0 | PT | 10009955 | Colon cancer stage III | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase III double-blind placebo-controlled Randomised Trial 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.
|
Randomised Controlled | Double | [{"id":7616,"code":2,"name":"Investigator"},{"id":7617,"code":1,"name":"Subject"},{"id":7619,"code":3,"name":"Monitor"},{"id":7618,"code":5,"name":"Carer"}] | Low-dose acetylsalicylic acid (80 mg): Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy. Placebo: Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy. |
Regulatory references
- Scientific advice from competent authorities
- METC Leiden Den Haag Delft, Central Committee On Research Involving Human Subjects
| EU CT number | Title | Sponsor |
|---|---|---|
| 2017-001397-41 | A Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients, De rol van aspirine op de overleving van patiënten met dikkedarmkanker; een fase III dubbel blinde placebo gecontroleerde gerandomiseerde studie |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 11
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 5 year Overall Survival (5y-OS)
Secondary endpoints 2
- Disease Free Survival (DFS)
- Time to Treatment Failure (TTF)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leiden University Medical Center
- Sponsor organisation
- Leiden University Medical Center
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leiden University Medical Center
- Contact name
- Clinical Research Center, dept. of Surgery
Public contact point
- Organisation
- Leiden University Medical Center
- Contact name
- Clinical Research Center, dept. of Surgery
Locations
1 EU/EEA country · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 1,588 | 36 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Medical Oncology, Tegelseweg 210, 5912 BL, Venlo
Medisch Spectrum Twente
Surgery, Koningsplein 1, 7512 KZ, Enschede
Stichting Catharina Ziekenhuis
Medical Oncology, Michelangelolaan 2, 5623 EJ, Eindhoven
Deventer Ziekenhuis
Medical Oncology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Stichting Sint Antonius Ziekenhuis
Medical Oncology, Koekoekslaan 1, 3435 CM, Nieuwegein
Stichting Alrijne Zorggroep
Surgery, Simon Smitweg 1, 2353 GA, Leiderdorp
Antonius Ziekenhuis
Medical Oncology, Bolswarderbaan 1, 8601ZK, Sneek
Stichting Ziekenhuis Gelderse Vallei
Medical Oncology, Willy Brandtlaan 10, 6716 RP, Ede Gld
Spaarne Gasthuis
Medical Oncology, Spaarnepoort 1, 2134 TM, Hoofddorp
ZorgSaam Ziekenhuis
Medical Oncology, Wielingenlaan 2, 4535 PA, Terneuzen
Reinier De Graaf
Surgery, Reinier De Graafweg 5, 2625 AD, Delft
Elkerliek Ziekenhuis
Medical Oncology, Wesselmanlaan 25, 5707 HA, Helmond
Medical Center Haaglanden
Surgery, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Beatrix Ziekenhuis
Medical Oncology, Banneweg 57, 4204AA, Gorinchem
Ikazia Ziekenhuis
Surgery, Montessoriweg 1, 3083 AN, Rotterdam
Ziekenhuis St Jansdal
Medical Oncology, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
MC Zuiderzee
Surgery, Ziekenhuisweg 100,, 8233AA, Lelystad
Slingeland Ziekenhuis
Medical Oncology, Kruisbergseweg 25, 7009 BL, Doetinchem
Amphia Hospital
Medical Oncology, Molengracht 21, 4818 CK, Breda
IJsselland Ziekenhuis
Medical Oncology, Prins Constantijnweg 2, 2906ZC, Capelle aan den IJssel
Meander Medical Center
Surgery, P. O. Box 1502, 3800 BM, Amersfoort
Streekziekenhuis Koningin Beatrix
Medical Oncology, Beatrixpark 1, 7101BN, Winterswijk
Wilhelmina Ziekenhuis
Medical Oncology, Europaweg-Zuid 1, 9401RK, Assen
Ziekenhuis Nij Smellinghe
Surgery, Compagnonsplein 1, 9202 NN, Drachten
LangeLand Ziekenhuis
Medical Oncology, Toneellaan 1, 2725NA, Zoetermeer
Adrz
Medical Oncology, 's-Gravenpolderseweg 114, 4462 RA, Goes
Vlietland Ziekenhuis
Medical Oncology, Vlietlandplein 2, 3118JH, Schiedam
Elisabeth-TweeSteden Ziekenhuis
Medical Oncology, Dr. Deelenlaan 5, 5042AD, Tilburg
Leiden University Medical Center
Surgery, Albinusdreef 2, 2333 ZA, Leiden
Máxima MC
Surgery, Dominee Theodor Fliednerstraat 1, 5631BM, Eindhoven
Stichting OLVG
Surgery, Oosterpark 9, 1091 AC, Amsterdam
Stichting Ziekenhuisgroep Twente
Surgery, Zilvermeeuw 1, 7609 PP, Almelo
Green Heart Hospital
Surgery, Bleulandweg 10, 2803 HH, Gouda
Spaarne Gasthuis
Surgery, Boerhaavelaan 22, 2035RC, Haarlem
Stichting Diakonessenhuis
Medical Oncology, Bosboomstraat 1, 3582 KE, Utrecht
Haga Hospital
Medical Oncology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2014-08-05 | 2015-01-08 | 2022-12-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-23 | Netherlands | Acceptable 2023-02-13
|
2023-02-13 |