Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours

Inclusion Criteria

• •Written informed consent
• •WHO performance status 0, 1 or 2
• •Participants should not be and have no intention of pregnancy or breast feeding during trial treatment
• •Previous or current participants of other primary treatment trials if agreed in advance between trials
• •No clinical or radiological evidence of residual or distant disease
• •Men or women with histologically confirmed invasive breast cancer
• •Undergone complete primary invasive tumour excision with clear margins
• •Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection
• •In those patients with a positive sentinel node biopsy:
• •o 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
• •o If 4 or more nodes are involved, patients must have undergone completion axillary node dissection
• •Radiotherapy (RT)
• •* Patients who have undergone breastconserving surgery should have received adjuvant RT
• •* Patients who have undergone mastectomy should have received RT if they have more than 3 axillary lymph nodes involved
• •* Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) have received radiation per institutional practice
• •Final histology must fall within at least one of these 3 groups:
• •* Node positive
• •* Node negative with highrisk features 2 or more of:
• •1. ER negative
• •2. HER2 positive
• •3. Grade 3
• •4. Lymphovascular invasion present
• •5. Age \<35
• •6. Oncotype Dx score of \>25
• •Known HER2 and ER status
• •Timing of entry
• •o If no adjuvant chemotherapy or RT: registration within 12 wks of definitive surgery achieving clear margins
• •o Following adjuvant chemotherapy/RT: registration within 8 wks of last therapy.
• •Participants may receive endocrine therapy and trastuzumab. All ER positive patients should be planned to undergo at least 5 yrs of adjuvant endocrine therapy.
• •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
• •Patients with synchronous tumours if one of the tumours is at least stage II or III
• •Serum CEA ideally ≤1.5 x upper limit of normal
• •Have undergone curative (R0) resection with clear margins
• •Timing of entry:
• •* If no adjuvant treatment: registration within 12 wks of definitive surgery achieving clear margins
• •Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the oesophagus, gastrooesophageal junction or stomach
• •Have undergone curative (R0) resection with clear margins or primary chemoRT given with curative intent
• •Timing of entry:
• •* Following surgery without adjuvant treatment: registration within 12 wks of the definitive surgery achieving clear margins
• •* Following primary chemoRT or surgery with adjuvant treatment: registration within 8 wks of last therapy
• •Men with histologically confirmed node negative nonmetastatic adenocarcinoma of the prostate
• •Have undergone curative treatment, either:
• •* Radical prostatectomy
• •* Radical RT
• •Intermediate or high risk according to D'Amico classification Depending on the curative treatment pathway, participant must additionally satisfy the following (a) Prostatectomy patients
• •Open, laparoscopic or robotic radical prostatectomy
• •Men treated with immediate adjuvant RT
• •Men receiving adjuvant hormone therapy planned for a maximum duration of 3 yrs
• •Timing of entry:
• •* If no adjuvant RT: registration within 12 wks of definitive surgery and PSA at ≥6 weeks postsurgery must be \<0.1ng/ml
• •* Following adjuvant RT: registration within 8 wks of delivery of final fraction of RT
• •* Men treated with salvage RT following a rise in PSA
• •Men randomised to RADICALSHD (ISRCTN 40814031) provided all other eligibility criteria are met (b) Radical RT patients
• •Men receiving neoadjuvant and/or adjuvant hormone therapy planned for a maximum duration of 3yrs
• •Timing of registration within 8wks from completion of RT (c) Salvage RT patients after previous Radical Prostatectomy
• •Men treated with salvage RT following a rise in PSA
• •Men receiving neoand/ or adjuvant hormone therapy planned for a maximum of 3yrs