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.

ISRCTN ISRCTN59865116
DOI https://doi.org/10.1186/ISRCTN59865116
EudraCT/CTIS number 2004-001484-21
ClinicalTrials.gov number NCT00427713
Secondary identifying numbers CHRONICLE
Submission date
16/10/2003
Registration date
11/11/2003
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-or-no-chemotherapy-after-surgery-for-rectal-cancer

Contact information

Dr R.G.T. Glynne-Jones
Scientific

Mount Vernon Centre for Cancer Treatment
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Phone +44 (0)1923 844012
Email rob.glynne-jones@whht.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleChemotherapy 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.
Study acronymCHRONICLE
Study objectivesLocally 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLocally advanced rectal cancer
InterventionRandomisation 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Capecitabine, oxaliplatin
Primary outcome measureThree year disease free survival of 85% power to detect a 10% increase i.e. 40% to 50%.
Secondary outcome measures1. Overall survival
2. Toxicity
Overall study start date01/11/2004
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants800
Total final enrolment113
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2004
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Mount Vernon Centre for Cancer Treatment
Northwood
HA6 2RN
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (ref: C10568/A4148)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2007 Yes No
Plain English results 25/10/2022 No Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
19/03/2020: EudraCT number added.