Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr R.G.T. Glynne-Jones
ORCID ID
Contact details
Mount Vernon Centre for Cancer Treatment
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
+44 (0)1923 844012
rob.glynne-jones@whht.nhs.uk
Additional identifiers
EudraCT number
2004-001484-21
ClinicalTrials.gov number
NCT00427713
Protocol/serial number
CHRONICLE
Study information
Scientific title
Chemotherapy or no chemotherapy in clear margins after neoadjuvant chemoradiation in locally advanced rectal cancer. A randomised phase III trial of control vs capecitabine plus oxaliplatin.
Acronym
CHRONICLE
Study hypothesis
Locally advanced rectal cancer is difficult to manage. Pre-operative chemoradiotherapyis used increasingly in the UK to downstage and treat the disease. The value of further postoperative chemotherapy is a matter of widespread debate. The role of 5-FU in this setting is being addressed in other studies. The aimof this trial is to determine whether a non-cross resistant chemotherapy will achieve a better outcome for patients. This trial also provides a unique opportunity to collect pathological specimens before and after chemoradiationfor analysis of predictors of response and resistance to 5-FU based chemoradiation.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Locally advanced rectal cancer
Intervention
Randomisation between:
Interventions:
Arm A: Control, standard follow-up
Arm B: six cycles at three weekly intervals (18 weeks):
a. Capecitabine 1000mg/m^2 on day one to day 14, twice daily
b. Oxaliplatin 130 mg/m^2 on day one by 120 minute intravenous infusion
Assessments:
Six, 12, 18, 24 and 36 months - abdomino-pelvic Computed Tomography (CT) scan or UltraSound (US) and chest x-ray or thoracic CT
Follow-up:
Three monthly for two years, six monthly next three years then annually
Intervention type
Drug
Phase
Phase III
Drug names
Capecitabine and Oxaliplatin
Primary outcome measure
Three year disease free survival of 85% power to detect a 10% increase i.e. 40% to 50%.
Secondary outcome measures
1. Overall survival
2. Toxicity
Overall trial start date
01/11/2004
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 and over
2. Histologically proven locally advanced rectal carcinoma
3. Pre-operative fluoropyrimidine based chemoradiation, minimum dose 45 Gy
4. Complete resection of primary tumour with clear margins
5. Able to start treatment within 12 weeks of surgery
6. Normal Full Blood Counts (FBCs), Urea and Electrolytes (U+Es) and Liver Function Tests (LFTs)
7. Creatinine clearance more than or equal to 50 ml/min
8. World Health Organisation performance status less than two
9. Patient consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
800
Participant exclusion criteria
1. Unsuitable for chemotherapy:
a. known DPD deficiency
b. hypersensitivity to platinum
c. not recovered from surgery
d. peripheral neuropathy
e. moderate or severe renal impairment
f. malabsorbtion syndrome
2. Prior oxaliplatin, irinotecan and mitomycin
3. Taking warfarinor antiviral agents
4. Previous malignancies or serious uncontrolled medical conditions
Recruitment start date
01/11/2004
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mount Vernon Centre for Cancer Treatment
Northwood
HA6 2RN
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (ref: C10568/A4148)
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17434299
Publication citations
-
Results
Glynne-Jones R, Meadows H, Wood W, Chemotherapy or no chemotherapy in clear margins after neoadjuvant chemoradiation in locally advanced rectal cancer: CHRONICLE. A randomised phase III trial of control vs. capecitabine plus oxaliplatin., Clin Oncol (R Coll Radiol), 2007, 19, 5, 327-329, doi: 10.1016/j.clon.2007.03.003.