ARISTOTLE: a phase III trial comparing standard versus novel chemoradiation... | Not Recruiting
ARISTOTLE: a phase III trial compar... | Not Recruiting
ARISTOTLE: a phase III trial comparing standard versus novel chemoradiation treatment (CRT) as pre-operative treatment for magnetic resonance imaging (MRI)-defined locally advanced rectal cancer
ARISTOTLE

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Medical Conditions
  • Locally advanced rectal cancer
Primary Contact Details
Prof David Sebag-Montefiore
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN09351447
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
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-standard-treatment-with-without-irinotecan-cancer-rectum-aristotle
Research Details
  • Some patients with rectal cancer benefit from receiving chemotherapy and radiotherapy before they have an operation to remove their cancers. This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer.
Phase
Phase III
Study Design
Two-arm phase III multicentre randomised controlled trial
Study Type
Interventional
Intervention

Arm A: capecitabine 900 mg/m^2 orally twice daily Monday to Friday for five weeks with radiotherapy 45 Gy in 25 fractions.
Arm B: irinotecan 60 mg/m^2 intravenously (IV) once weekly, weeks 1 - 4 and capecitabine 650 mg/m^2 orally twice daily Monday to Friday for five weeks with radiotherapy 45 Gy in 25 fractions.

All patients will be followed up for 5 years.

Intervention Type
Drug
Primary Outcome Measures
    Current primary outcome measures as of 01/06/2016:
    Disease free survival at 3 years

    Previous primary outcome measures:
    Disease free survival, assessed at four planned stages during the trial
Secondary Outcome Measures
    Current secondary outcome measures as of 01/06/2016:
    1. Disease-specific survival
    2. Loco-regional failure
    3. Overall survival
    4. Histopathologically confirmed circumferential resection margin (CRM) negative resection rate
    5. Histopathological complete response pathological complete response (pCR)
    6. Histopathologically quantitated tumour cell density
    7. Surgical morbidity
    8. Health-related Quality of Life (QoL) and functional outcome

    Previous secondary outcome measures:
    1. Disease-specific survival
    2. Loco-regional failure
    3. Overall survival
    4. Histopathologically confirmed circumferential resection margin (CRM) negative resection rate
    5. Histopathological complete response pathological complete response (pCR)
    6. Surgical morbidity
    7. Functional outcome
    8. Quality of life
    9. Resource use

    Assessments weekly during treatment phase and then at 2 and 4 weeks after completion of treatment, and then 4 - 6 weeks after completion of treatment.
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
600
Participant Inclusion Criteria
    Current inclusion criteria as of 01/06/2016:
    1. Diagnosis of primary rectal cancer
    2. Histologically confirmed invasive adenocarcinoma
    3. Pelvic MRI defined disease (one of the following):
    3.1. Mesorectal fascia involved or breached
    3.1.1. Includes involvement of adjacent organ
    3.2. Mesorectal fascia threatened (tumour ≤ 1 mm from mesorectal fascia) includes:
    3.2.1. Primary tumour ≤ 1 mm from mesorectal fascia or
    3.2.2. Extra-mural vascular invasion ≤ 1 mm from mesorectal fascia or
    3.2.3. Tumour deposit with irregular border and mixed signal intensity ≤ 1 mm from mesorectal fascia
    3.3. Low tumours at/below level of levators where:
    3.3.1. Tumour ≤ 1 mm from levator on two imaging planes or
    3.3.2. Tumour through full thickness of muscularis propria or beyond at level of puborectalis sling or below or
    3.3.3. Tumour involving the intersphincteric plane or
    3.3.4. Tumour involving the external anal sphincter
    3.3.5. Patients with enlarged pelvic side wall nodes are eligible only if they also meet at least one of the above criteria.
    4. Superior extent of macroscopic tumour no higher than S1/2 junction on saggital MRI
    5. ECOG performance status 0 or 1
    6. Considered fit to receive all trial treatments
    7. Bowel function controlled with ≤ 6 mg loperamide per day
    8. Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L
    9. Serum transaminase < 3 x ULN
    10. Adequate renal function (Cockcroft-Gault estimation ≥ 50 mL/min)
    11. Bilirubin < 1.5 x ULN
    12. Able to swallow oral medication
    13. Willing and able to give informed consent and comply with treatment and follow-up schedule
    14. Aged 18 or over

    Previous inclusion criteria:
    1. Mesorectal fascia involved
    2. Mesorectal fascia threatened (tumour less than 1 mm from mesorectal fascia)
    3. Low tumours arising less than 5 cm from the anal verge
    4. Patients aged 18 years and over, both male and female patients
Participant Exclusion Criteria
    Current exclusion criteria as of 01/06/2016:
    1. Previous radiotherapy to the pelvis (including brachytherapy)
    2. Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation)
    3. Unequivocal evidence of metastatic disease (includes resectable metastases)
    3.1. Patients with equivocal lesions (determined at MDT) are eligible
    4. Major disturbance of bowel function (e.g. gross faecal incontinence or requiring > 6 mg loperamide each day)
    5. History of another malignancy within the last 5 years except successfully treated non-melanoma cancer of skin or carcinoma in situ of uterine cervix
    6. Known dihydropyrimidine dehydrogenase (DPYD) deficiency
    7. Known Gilberts disease (hyperbilirubinaemia)
    8. Taking warfarin that cannot be discontinued at least 7 days prior to starting treatment
    9. Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine
    10. Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
    11. Pregnant, lactating, or pre menopausal women not using adequate contraception
    12. Oral St John’s Wort therapy that cannot be discontinued at least 14 days prior to starting treatment
    13. Unfit to receive any study treatment or subsequent surgical resection

    Previous exclusion criteria:
    1. Patients unable or unfit to receive all study treatment
    2. World Health Organization (WHO) performance status greater than or equal to 2
    3. Metastatic disease
    4. Pregnant or lactating
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)
-
Trial Contact(s)
Primary Trial Contact
Prof David Sebag-Montefiore
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
ARISTOTLE: Advanced Rectal study wIth Standard Therapy Or a novel agent, Total mesorectal excision (TME) and Long term Evaluation
EudraCT Number
2008-005782-59
Funder(s)
  • Cancer Research UK (CRUK) (UK) (ref: C19942/A10016)
Other Study ID Numbers
Version 5.1
Sponsor(s)
Cancer Research UK and UCL Cancer Trials Centre (UK)
Key Dates

Recruitment Start Date

25 Oct 2011

Recruitment End Date

25 Oct 2017

Trial Start Date

22 Sep 2011

Trial End Date

25 Oct 2022

Date added to source

08 Sep 2009

Date updated in source

01 Jun 2016