Capecitabine and Oxaliplatin or Standard Follow-Up Care in Treating Patients Who Have Undergone Surgery for Locally Advanced Rectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00427713
- Lead Sponsor
- Cancer Research UK
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving capecitabine together with oxaliplatin is more effective than standard follow-up care in treating rectal cancer that was removed by surgery.
PURPOSE: This randomized phase III trial is studying capecitabine and oxaliplatin to see how well they work compared with standard follow-up care in treating patients who have undergone surgery for locally advanced rectal cancer.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of adjuvant chemotherapy comprising capecitabine and oxaliplatin vs standard follow-up care, in terms of disease-free and overall survival, in patients with clear margins after complete resection of locally advanced rectal cancer.
OUTLINE: This is an open-label, randomized, controlled, prospective, multicenter study. Patients are stratified according to surgeon and nodal status (node positive vs node negative vs unknown). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo standard follow up.
* Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival at 3 years
- Secondary Outcome Measures
Name Time Method Overall survival at 5 years Toxicity
Trial Locations
- Locations (72)
Wansbeck General Hospital
🇬🇧Ashington, England, United Kingdom
Good Hope Hospital
🇬🇧Birmingham, England, United Kingdom
Furness General Hospital
🇬🇧Barrow in Furness, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
🇬🇧Hull, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Royal Bolton Hospital
🇬🇧Farnworth, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, England, United Kingdom
Kidderminster Hospital
🇬🇧Kidderminster Worcestershire, England, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Royal Albert Edward Infirmary
🇬🇧Lancanshire, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Whittington Hospital
🇬🇧London, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
St. Mary's Hospital
🇬🇧Newport, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Hope Hospital
🇬🇧Salford, England, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Pilgrim Hospital
🇬🇧Boston, England, United Kingdom
Princess Alexandra Hospital
🇬🇧Essex, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
King George Hospital
🇬🇧Ilford, Essex, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
UCL Cancer Institute
🇬🇧London, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Southport and Formby District General Hospital
🇬🇧Southport, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Kingston Hospital
🇬🇧Surrey, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Sandwell General Hospital
🇬🇧West Bromwich, England, United Kingdom
Worcester Royal Hospital
🇬🇧Worcester, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Royal Glamorgan Hospital
🇬🇧Lhantrisant, Wales, United Kingdom
Hereford Hospitals
🇬🇧Hereford, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, Essex, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
University Hospital of North Durham
🇬🇧Durham, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom