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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
22/09/2011
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Prof David Sebag-Montefiore
Recruitment target:
600
EudraCT number:
2008-005782-59
Contact details:
ctc.aristotle@ucl.ac.uk
Lay summary:
ARISTOTLE
A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer
Description
Design:

ARISTOTLE is a multicentre, phase III, randomised trial comparing standard neoadjuvant chemoradiotherapy (CRT) of oral capecitabine and radiotherapy versus standard CRT with the addition of irinotecan. 

Patients with MRI defined locally advanced, non-metastatic rectal cancer will be allocated in a 1:1 ratio to the two treatment arms.
Treatment:

All patients will receive 25 fractions of radiotherapy (total of 45 Gy) and 5 weeks of capecitabine, on days 1-5 of each week. Patients randomised to the experimental arm will receive a second drug, irinotecan once a week during treatment weeks 1-4. 

Arm A:
  • Capecitabine 900 mg/m2,orally twice daily on days of radiotherapy only
  • Radiotherapy 45 Gyin 25 fractions
Arm B:

  • Capecitabine 650 mg/m2, orally twicedaily on days of radiotherapy only
  • Radiotherapy 45 Gy in 25 fractions
  • Irinotecan 60 mg/m2, IV once weekly, weeks 1-4 only

Surgery for all patients will be scheduled 8-10 weeks after completion of CRT, and followed-up for 5 years from the end of CRT.
Key inclusion/exclusion criteria:

Eligible patients must have pelvic MRI defined, locally advanced, non-metastatic primary rectal adenocarcinoma. ECOG performance status of 0-1, no prior pelvis radiotherapy, uncontrolled cardiorespiratory co-morbidity, major disturbances of bowel function or unequivocal evidence of metastatic disease. 
Duration of recruitment:

6 years 9 months
Aim

The overall aim is to determine whether the addition of irinotecan to the standard oral chemotherapy treatment of capecitabine and radiotherapy improves outcome. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
*Guide to Downloading & Extract Docs from UCL CTC WebsiteN/A Current
02. ARISTOTLE_Protocol (current)N/A Current 08/02/2021
02. ARISTOTLE_Protocol Version History LogN/A Current 08/02/2021
Trial documents
NameTypeVersionCurrent versRelease dateDownload
01. Trial Management (1)OtherN/A Current
01. Trial Management (2)OtherN/A Current
01. Trial Management (3)OtherN/A Current
02. Protocol_Superseded (1)OtherN/A Current
02. Protocol_Superseded (2)OtherN/A Current
02. Protocol_Superseded (3)OtherN/A Current
02. Protocol_Superseded (4)OtherN/A Current
02. Protocol_Superseded (5)OtherN/A Current
03. Patient InformationOtherN/A Current
04. Ethics and MHRA (1)OtherN/A Current
04. Ethics and MHRA (2)OtherN/A Current
04. Ethics and MHRA (3)OtherN/A Current
04. Ethics and MHRA (4)OtherN/A Current
05. Agreements & ContractsOtherN/A Current
06. Site and Staff InformationOtherN/A Current
07. Patient Screening and RecruitmentOtherN/A Current
08. LaboratoryOtherN/A Current
09. Summary of Product Characteristics (SPC) (1)_CurrentOtherN/A Current
09. Summary of Product Characteristics (SPC) (2)_SupersededOtherN/A Current
09. Summary of Product Characteristics (SPC) (3)_SupersededOtherN/A Current
10. PharmacyOtherN/A Current
11. DATA MANAGEMENT (1)OtherN/A Current
11. DATA MANAGEMENT (2a)_CurrentOtherN/A Current
11. DATA MANAGEMENT (2b)_CurrentOtherN/A Current
11. DATA MANAGEMENT (3a)_SupersededOtherN/A Current
11. DATA MANAGEMENT (3b)_SupersededOtherN/A Current
12. Pharmacovigilance (PV)OtherN/A Current
13. Incident ReportingOtherN/A Current
14. MonitoringOtherN/A Current
16. Regulatory GuidelinesOtherN/A Current
17. Other Study MaterialsOtherN/A Current
ARISTOTLE_QC Checklist_ISFOther24/09/2020 Current
ARISTOTLE_QC Checklist_PSFOther24/09/2020 Current
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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