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.

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.

Contact the trial team

View trial summary

View trial documents

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.

Name	Version	Current vers	Release date
*Guide to Downloading & Extract Docs from UCL CTC Website	N/A	Current
01. ARISTOTLE_Protocol (current)	7.1	Current	03/11/2022
02. ARISTOTLE_Protocol Version History Log	N/A	Current	04/11/2022

Trial documents

Name	Type	Version	Current vers	Release date
01. Trial Management (1)	Other	N/A	Current	25/11/2022
01. Trial Management (2)	Other	N/A	Current	25/11/2022
01. Trial Management (3)	Other	N/A	Current	25/11/2022
02. Protocol_Superseded (1)	Other	N/A	Current	25/11/2022
02. Protocol_Superseded (2)	Other	N/A	Current	25/11/2022
02. Protocol_Superseded (3)	Other	N/A	Current	25/11/2022
02. Protocol_Superseded (4)	Other	N/A	Current	25/11/2022
03. Patient Information	Other	N/A	Current	25/11/2022
04. Ethics and MHRA (1)	Other	N/A	Current	25/11/2022
04. Ethics and MHRA (2)	Other	N/A	Current	25/11/2022
04. Ethics and MHRA (3)	Other	N/A	Current	25/11/2022
04. Ethics and MHRA (4)	Other	N/A	Current	25/11/2022
04. Ethics and MHRA (5)	Other	N/A	Current	25/11/2022
05. Agreements & Contracts	Other	N/A	Current	25/11/2022
06. Site and Staff Information	Other	N/A	Current	25/11/2022
07. Patient Screening and Recruitment	Other	N/A	Current	25/11/2022
08. Laboratory	Other	N/A	Current	25/11/2022
09. Summary of Product Characteristics (SPC) (1)_Current	Other	N/A	Current	25/11/2022
09. Summary of Product Characteristics (SPC) (2)_Superseded	Other	N/A	Current	25/11/2022
09. Summary of Product Characteristics (SPC) (3)_Superseded	Other	N/A	Current	25/11/2022
10. Pharmacy	Other	N/A	Current	25/11/2022
11. Data Management (1)	Other	N/A	Current	25/11/2022
11. Data Management (2a)_Current	Other	N/A	Current	25/11/2022
11. Data Management (2b)_Current	Other	N/A	Current	25/11/2022
11. Data Management (3a)_Superseded	Other	N/A	Current	25/11/2022
11. Data Management (3b)_Superseded	Other	N/A	Current	25/11/2022
12. Pharmacovigilance (1)	Other	N/A	Current	25/11/2022
12. Pharmacovigilance (2)	Other	N/A	Current	25/11/2022
13. Incident Reporting	Other	N/A	Current	25/11/2022
14. Monitoring	Other	N/A	Current	25/11/2022
16. Regulatory Guidelines	Other	N/A	Current	25/11/2022
17. Other Study Materials	Other	N/A	Current	25/11/2022
ARISTOTLE_QC Checklist_ISF	Other	25/11/2022	Current
ARISTOTLE_QC Checklist_PSF	Other	25/11/2022	Current

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:
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