Add-Aspirin: the effects of aspirin on disease recurrence and survival afte... | Recruiting
Add-Aspirin: the effects of aspirin... | Recruiting
Add-Aspirin: the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.

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Medical Conditions
  • Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN74358648
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-whether-aspirin-can-stop-cancer-coming-back-after-treatment-add-aspirin
Research Details
  • 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.

Phase
Phase III
Study Design
Randomised; Interventional
Study Type
Interventional
Intervention

1. Randomised blinded phase: Participants will be randomly assigned to 100mg aspirin, 300mg 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 100mg aspirin daily for a run-in period of approximately 8 weeks prior to randomisation

Intervention Type
Other
Primary Outcome Measures
    Overall survival
Secondary Outcome Measures
    N/A
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 11000; UK Sample Size: 9189
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Aviation House 125 Kingsway
London
WC2B 6NH
Trial Contact(s)
Primary Trial Contact
Dr Marta Campos
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
EudraCT Number
2013-004398-28
Funder(s)
  • National Institute for Health Research
  • Cancer Research UK
Other Study ID Numbers
18067
Sponsor(s)
University College London
Key Dates

Recruitment Start Date

01 Mar 2015

Recruitment End Date

28 Feb 2021

Trial Start Date

01 Mar 2015

Trial End Date

28 Feb 2021

Date added to source

21 Jan 2015

Date updated in source

03 Nov 2015