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
Note: For enquiries only. DO NOT use for clinical referrals.
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
01. ARISTOTLE_Protocol (current)7.1 Current 03/11/2022
02. ARISTOTLE_Protocol Version History LogN/A Current 04/11/2022
Trial documents
NameTypeVersionCurrent versRelease dateDownload
01. Trial Management (1)OtherN/A Current 25/11/2022
01. Trial Management (2)OtherN/A Current 25/11/2022
01. Trial Management (3)OtherN/A Current 25/11/2022
02. Protocol_Superseded (1)OtherN/A Current 25/11/2022
02. Protocol_Superseded (2)OtherN/A Current 25/11/2022
02. Protocol_Superseded (3)OtherN/A Current 25/11/2022
02. Protocol_Superseded (4)OtherN/A Current 25/11/2022
03. Patient InformationOtherN/A Current 25/11/2022
04. Ethics and MHRA (1)OtherN/A Current 25/11/2022
04. Ethics and MHRA (2)OtherN/A Current 25/11/2022
04. Ethics and MHRA (3)OtherN/A Current 25/11/2022
04. Ethics and MHRA (4)OtherN/A Current 25/11/2022
04. Ethics and MHRA (5)OtherN/A Current 25/11/2022
05. Agreements & ContractsOtherN/A Current 25/11/2022
06. Site and Staff InformationOtherN/A Current 25/11/2022
07. Patient Screening and RecruitmentOtherN/A Current 25/11/2022
08. LaboratoryOtherN/A Current 25/11/2022
09. Summary of Product Characteristics (SPC) (1)_CurrentOtherN/A Current 25/11/2022
09. Summary of Product Characteristics (SPC) (2)_SupersededOtherN/A Current 25/11/2022
09. Summary of Product Characteristics (SPC) (3)_SupersededOtherN/A Current 25/11/2022
10. PharmacyOtherN/A Current 25/11/2022
11. Data Management (1)OtherN/A Current 25/11/2022
11. Data Management (2a)_CurrentOtherN/A Current 25/11/2022
11. Data Management (2b)_CurrentOtherN/A Current 25/11/2022
11. Data Management (3a)_SupersededOtherN/A Current 25/11/2022
11. Data Management (3b)_SupersededOtherN/A Current 25/11/2022
12. Pharmacovigilance (1)OtherN/A Current 25/11/2022
12. Pharmacovigilance (2)OtherN/A Current 25/11/2022
13. Incident ReportingOtherN/A Current 25/11/2022
14. MonitoringOtherN/A Current 25/11/2022
16. Regulatory GuidelinesOtherN/A Current 25/11/2022
17. Other Study MaterialsOtherN/A Current 25/11/2022
ARISTOTLE_QC Checklist_ISFOther25/11/2022 Current
ARISTOTLE_QC Checklist_PSFOther25/11/2022 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
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