Add Aspirin

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:

a. 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

b. If 4 or more nodes are involved, patients must have undergone completion axillary node dissection

5. Radiotherapy (RT)

a. Patients who have undergone breastconserving

surgery should receive adjuvant RT

b. Patients who have undergone mastectomy should receive RT if they have more than 3 axillary lymph nodes involved

c. 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:

a. Node positive

b. Node negative with highrisk

features 2

or more of:

i. ER negative

ii. HER2 positive

iii. Grade 3

iv. Lymphovascular invasion present

v. Age <35

vi. Oncotype Dx score of >25

c. 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

GASTROOESOPHAGEAL

COHORT INCLUSION CRITERIA

1. Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the

oesophagus, gastrooesophageal

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:

a. Radical prostatectomy

b. Radical RT

c. Salvage RT (following rise in PSA after prostatectomy)

3. Intermediate or high risk according to D’Amico classification

Treatment pathway specific inclusion criteria:

(a) Prostatectomy patients

4. Open, laparoscopic or robotic radical prostatectomy

5. Men treated with immediate adjuvant RT

6. Men receiving adjuvant hormone therapy planned for a maximum duration of 3 yrs

7. Men randomised to any of the 3 arms of RADICALS HD are eligible

(b) Radical RT patients

9. Men receiving neoadjuvant

and/or adjuvant hormone therapy planned for a

maximum duration of 3yrs

(c) Salvage RT patients following PSA rise after previous radical prostatectomy

13. Men treated with salvage RT following a rise in PSA are eligible

14. Men receiving neoand/

or adjuvant hormone therapy planned for a maximum of

3yrs

15. Men randomised to any of the 3 arms of RADICALS HD are eligible 

Participants must not meet any of the common or their tumourspecific

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:

DCIS

where treatment consisted of resection alone.

Prostate

cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in

PSA.

Cervical

carcinoma in situ where treatment consisted of resection alone.

Basal

cell carcinoma where treatment consisted of resection alone or radiotherapy.

Superficial

bladder carcinoma where treatment consisted of resection alone.

Other

cancers where the patient has been diseasefree

for ≥15 years.

10. Any other physical condition which is associated with increased risk of aspirinrelated

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 highrisk

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).

GASTROOESOPHAGEAL

COHORT EXCLUSION CRITERIA

1. Proven (or clinically suspected) metastatic disease.

PROSTATE 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. 

Research Nurse: Emma Davies (Tel/Ext. No) emma.davies16@nhs.net

Administrator: Arun Prakash