Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C61- Malignant neoplasm of prostate Health Condition 3: C20- Malignant neoplasm of rectum Health Condition 4: null- Patients suffering from breast cancer and gastroesophageal cancer
Conditions
Interventions
Intervention1: Aspirin tablet: 100mg and 300mg aspirin tablets.
Patients will undergo a double-blind randomisation and will be allocated in a 1:1:1 ratio to either 100mg aspirin, 300mg aspirin or mat
Sponsors
Medical Research Council Clinical Trials Unit
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Common Inclusion Criteria: 1. Written informed consent 2. WHO performance status 0, 1, 2 or 3 3. No clinical or radiological evidence of residual or distant disease For Breast Cancer Cohort: 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 tumors 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 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 For Gastroesophageal Cancer Cohort: 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 For Prostate Cancer Cohort: 1.Men with histologically confirmed, node negative, non-metastatic adenocarcinoma, with clinical or radiological stagingof the prostate T1-3b, N0. See appendix VII for TNM staging definitions. 2.Have undergone curative treatment, either a.Radical prostatectomy. b.Radical radiotherapy (external beam or brachytherapy). c.Salvage radiotherapy following a rise in PSA after radical prostatectomy. 3.Intermediate or high risk according to Dââ?¬•Amico classification (prior to radical treatment). Also, patients who are low risk prior to prostatectomy but whose prostatectomy histology shows upstaging to pT3b, or a higher Gleason score of 7 or greater are also eligible, including those with microscopic N1 disease provided any additional ADT is not planned for more than 3 years. 4.Open, laparoscopic or robotic radical
Exclusion criteria
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 long term 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 6. Active or previous history of inflammatory bowel disease 7. History of moderate or severe renal impairment, with eGFR 8. Previous invasive or noninvasive malignancy except 8.1. DCIS where treatment consisted of resection alone. 8.2. Cervical carcinoma in situ where treatment consisted of resection alone. 8.3. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy 8.4. Superficial bladder carcinoma where treatment consisted of resection alone. 8.5. Other cancers where the patient has been disease free for 15 years. 9. 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, mascular degeneration and patients with a high risk of mortality from another cause within the trial treatment period 10. Known glucose6phosphate dehydrogenase deficiency 11. Known lactose intolerance 12. LFTs greater than 1.5x the upper limit of normal unless agreed with TMG 13. Anticipated difficulties in complying with trial treatment or follow-up schedules 14. Age less than 16 years old 15. Participants in other treatment trials where this has not been agreed in advance by both trial teams 16. Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period For Breast Cancer Cohort: 1. Metastatic or bilateral breast cancer For Gastroesophageal Cancer Cohort: 1. Proven (or clinically suspected) metastatic disease For Prostate Cancer Cohort: 1.Biopsy proven or radiologically suspected nodal involvement or distant metastases from prostate cancer. a.T4 patients are ineligible. 2.Adjuvant hormone therapy planned for >3years. 3.Bilateral orchidectomy. For Colorectal Cancer Cohort: 1.Proven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases (at any time) with clear margins and no residual metastatic disease are eligible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohorts combined: Overall survival-Time from randomisation to death. For Breast Cohort: Invasive Disease Free Survival- Time from randomisation to invasive disease or death. For GE Cohort: Overall Survival For Prostate Cohort: Biochemical recurrence-free survival-Time from randomisation to PSA failure,clinical progression, initiation of salvage treatment or prostate cancer death For Colorectal cohort: Disease-free survival-Time from randomisation to disease recurrence or death.Timepoint: months since randomisation: 3,6,9,12,18,24,30,36,42,48,54,60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate Cancer Cohort: 1. Prostate cancer-specific survival (PCSS): Time from randomisation to prostate cancer death 2. Time to initiation of salvage treatment : Time from randomisation to initiation of salvage treatment 3. Bone metastases-free survival : Time from randomisation to development of bone metastasis or death from any cause Colorectal Cancer cohort: 1. Colorectal cancer-specific survival : Time from randomisation to colorectal cancer deathTimepoint: months since randomisation: 3,6,9,12,18,24,30,36,42,48,54,60;Cohorts Combined: 1. Overall survival 2. Adherence 3. Toxicity 4. Serious haemorrhage 5. Serious vascular events 6. Thrombotic events 7. Diabetes and associated complications 8. Second malignancies 9. Age-related macular degeneration (AMD) 10. Cognitive assessment 11. Dementia 12. Functional capacity 13. Exercise levels 14. Long-term quality of life/late effects of cancer treatmentTimepoint: months since randomisation: 3,6,9,12,18,24,30,36,42,48,54,60;Breast Cancer Cohort: 1.Breast cancer-specific survival (time from randomisation to breast cancer death) 2. Bone metastases free survival (time from randomization to development of bone metastasis or death from any cause) 3. IDFS-DCIS (Defined as for IDFS except that ductal carcinoma insitu(DCIS-ipsilateral or contralateral) is additionally included as an event) Gastroesophageal Cancer Cohort: 1. Disease free survival (Time from randomization to disease recurrence or death from any cause)Timepoint: months since randomisation: 3,6,9,12,18,24,30,36,42,48,54,60 | — |
Countries
India, United Kingdom
Contacts
Public ContactDr C S Pramesh
Tata Memorial Hospital
Outcome results
None listed