Condition category
Cancer
Date applied
16/10/2003
Date assigned
11/11/2003
Last edited
23/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

ClinicalTrials.gov number

NCT00427713

Protocol/serial number

CHRONICLE

Study information

Scientific title

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 measures

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (ref: C10568/A4148)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17434299

Publication citations

  1. 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.

Additional files

Editorial Notes