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
Contact information
Dr R.G.T. Glynne-Jones
Scientific
Scientific
Mount Vernon Centre for Cancer Treatment
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
| Phone | +44 (0)1923 844012 |
|---|---|
| rob.glynne-jones@whht.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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. |
| Study acronym | CHRONICLE |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Capecitabine, 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 study start date | 01/11/2004 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Total final enrolment | 113 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mount Vernon Centre for Cancer Treatment
Northwood
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Cancer Research UK (ref: C10568/A4148)
Private sector organisation / Other non-profit organizations
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not 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.
