Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Contact information



Primary contact

Ms Alex Robbins


Contact details

2nd floor
Aviation House
90 High Holborn
United Kingdom



Additional contact

Ms Alex Robbins


Contact details

2nd floor
Aviation House
90 High Holborn
United Kingdom
+44 (0)20 7670-4906



Additional contact

Ms Tessa Dibble


Contact details

2nd floor
Aviation House
90 High Holborn
United Kingdom
+44 (0)207 670 4892

Additional identifiers

EudraCT number

2013-004398-28 number

Protocol/serial number


Study information

Scientific title

A phase III double-blind placebo-controlled randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.


Study hypothesis

Aim: To assess whether regular aspirin use after standard cancer therapy prevents recurrence and prolongs survival in patients with early stage common solid tumours. International recruitment will allow assessment of the intervention in different communities.

Ethics approval

14/SC/0171; First MREC approval date 04/06/2014

Study design

Randomised; Interventional

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet




1. Randomised blinded phase: Participants will be randomly assigned to 100 mg aspirin, 300 mg aspirin or matched placebo. All tablets will be enteric-coated to be taken daily for at least five years
2. Run-in feasibility phase: During the feasibility phase of the study, all participants will take open label 100 mg aspirin daily for a run-in period of approximately 8 weeks prior to randomisation

Intervention type



Phase III

Drug names

Primary outcome measure

Overall survival

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Common inclusion criteria:
1. Written informed consent
2. WHO performance status 0, 1 or 2
3. Previous or current participants of other primary treatment trials if agreed in advance between trials
4. No clinical or radiological evidence of residual or distant disease

Breast cohort inclusion criteria:
1. Men or women with histologically confirmed invasive breast cancer
2. Undergone complete primary invasive tumour excision with clear margins
3. Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection
4. In those patients with a positive sentinel node biopsy:
4.1. If 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further intervention) should be completed prior to registration
4.2. If 4 or more nodes are involved, patients must have undergone completion axillary node dissection
5. Radiotherapy (RT):
5.1. Patients who have undergone breast conserving surgery should receive adjuvant RT
5.2. Patients who have undergone mastectomy should receive RT if they have more than 3 axillary lymph nodes involved
5.3. Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) receive radiation per institutional practice
6. Final histology must fall within at least one of these 3 groups:
6.1. Node positive
6.2. Node negative with high risk features 2 or more of:
6.2.1. ER negative
6.2.2. HER2 positive
6.2.3. Grade 3
6.2.4. Lymphovascular invasion present
6.2.5. Age <35
6.2.6. Oncotype Dx score of >25
6.3. In patients who have received neoadjuvant chemotherapy, patients are eligible if they have both a hormone receptor negative/HER2 negative tumour, a HER2 positive tumour or a hormone receptor positive grade 3 tumour and did not achieve a pathological complete response with neoadjuvant systemic therapy
7. Patients who received standard neoadjuvant and/or adjuvant chemotherapy or RT are eligible
8. Known HER2 and ER status
9. Participants may receive endocrine therapy and trastuzumab. All ER positive patients should be planned to undergo at least 5 yrs of adjuvant endocrine therapy

Colorectal cohort inclusion criteria:
1. Histologically confirmed stage II or III adenocarcinoma of the colon or rectum and patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease
2. Patients with synchronous tumours if one of the tumours is at least stage II or III
3. Serum CEA ideally =1.5 x upper limit of normal
4. Have undergone curative (R0) resection with clear margins

Gastroesophageal cohort inclusion criteria:
1. Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the oesophagus, gastroesophageal junction or stomach
2. Have undergone curative (R0) resection with clear margins or primary chemoRT given with curative intent

Prostate cohort inclusion criteria:
1. Men with histologically confirmed node negative nonmetastatic
adenocarcinoma of the prostate
2. Have undergone curative treatment, either:
2.1. Radical prostatectomy
2.2. Radical RT
2.3. Salvage RT (following rise in PSA after prostatectomy)
3. Intermediate or high risk according to D’Amico classification

Treatment pathway specific inclusion criteria:
1. Prostatectomy patients:
1.2. Open, laparoscopic or robotic radical prostatectomy
1.3. Men treated with immediate adjuvant RT
1.4. Men receiving adjuvant hormone therapy planned for a maximum duration of 3 yrs
1.5. Men randomised to any of the 3 arms of RADICALS HD are eligible Prostatectomy patients
2. Radical RT patients:
2.1. Men receiving neoadjuvant and/or adjuvant hormone therapy planned for a
maximum duration of 3yrs
3. Salvage RT patients following PSA rise after previous radical prostatectomy:
3.1. Men treated with salvage RT following a rise in PSA are eligible
3.2. Men receiving neoand/or adjuvant hormone therapy planned for a maximum of 3yrs
3.3. Men randomised to any of the 3 arms of RADICALS HD are eligible

Participant type


Age group




Target number of participants

Planned Sample Size: 11000; UK Sample Size: 9189

Participant exclusion criteria

Participants must not meet any of the common or their tumour specific exclusion criteria.

Common exclusion criteria:
1. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication
2. A past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma, that is exacerbated by use of NSAIDs
3. Current use of anticoagulants
4. Current or longterm use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to longterm therapy
5. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of bleeding has been surgically removed
7. Active or previous history of inflammatory bowel disease
8. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2.
9. Previous invasive or noninvasive malignancy except:
9.1. DCIS where treatment consisted of resection alone.
9.2. Prostate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA.
9.3. Cervical carcinoma in situ where treatment consisted of resection alone.
9.4. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy.
9.5. Superficial bladder carcinoma where treatment consisted of resection alone.
9.6. Other cancers where the patient has been disease free for =15 years.
10. Any other physical condition which is associated with increased risk of aspirin related
morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, macular degeneration and patients with a high risk of mortality from another cause within the trial treatment period
11. Known glucose6phosphate dehydrogenase deficiency
12. Known lactose intolerance
13. LFTs greater than 1.5x the upper limit of normal unless agreed with TMG
14. Anticipated difficulties in complying with trial treatment or followup schedules
15. <16 years old
16. Participants in other treatment trials where this has not been agreed in advance by both trial teams
17. Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period

Breast cohort exclusion criteria:
1. Metastatic or bilateral breast cancer.

Colorectal cohort exclusion criteria:
1. Proven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease are eligible)

Gastroesophageal cohort exclusion criteria:
1. Proven (or clinically suspected) metastatic disease.

Prostrate cohort participant criteria:
1. Biopsy proven or radiologically suspected nodal involvement, or distant metastases from prostate cancer
2. Adjuvant hormone therapy planned for >3 years
3. Bilateral orchidectomy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Medical Research Council Clinical Trials Unit (MRC CTU)
Aviation House 125 Kingsway
United Kingdom

Sponsor information


University College London

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2020 feasibility analysis in (added 02/06/2020)

Publication citations

Additional files

Editorial Notes

11/06/2020: The public contacts have been added and the previous scientific contact removed. 02/06/2020: Publication reference added.