Capecitabine and Oxaliplatin or Standard Follow-Up Care in Treating Patients Who Have Undergone Surgery for Locally Advanced Rectal Cancer

NCT00427713 | Completed Phase 3

• 7 other identifiers: CDR0000526299CRUK-CHRONICLECRUK-BRD/05/132EU-20679ISRCTN59865116CTA21106/0016/001EUDRACT-2004-001484-21
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 72

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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage III rectal cancer; stage II rectal cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 3 years

Secondary Outcomes (2)

• Overall survival at 5 years

• Toxicity

Interventions

capecitabine DRUG

oxaliplatin DRUG

adjuvant therapy PROCEDURE

standard follow-up care PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * Within 15 cm of the anal verge * Locally advanced disease * Underwent complete resection of primary tumor within the past 12 weeks * ypT0-4, N0-2 with definitive histology at surgery * Circumferential resection margin \> 1 mm * No gross evidence of residual disease * Received neoadjuvant fluoropyrimidine-based chemoradiotherapy with ≥ 45 Gy planned total radiation dose, given in 1 of the following fashions: * Prolonged fluorouracil IV during radiotherapy * Low-dose leucovorin calcium and fluorouracil (days 1-5 and 29-33) concurrently with radiotherapy * Oral capecitabine concurrently with radiotherapy * No evidence of metastatic disease PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine clearance ≥ 50 mL/min * Bilirubin ≤ 1.25 times upper limit of normal (ULN) * AST and ALT ≤ 1.25 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No known dihydropyrimidine dehydrogenase deficiency * No hypersensitivity to platinum compounds * No preexisting peripheral neuropathy ≥ grade 1 * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No other serious uncontrolled medical condition or concurrent medical illness that would compromise life expectancy and/or preclude study compliance, including any of the following: * Serious uncontrolled infections * Significant cardiac disease (e.g., uncontrolled angina, congestive heart failure, cardiomyopathy, or arrhythmias) or myocardial infarction within the past 12 months * Interstitial pneumonia or symptomatic lung fibrosis * No other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin, unless disease-free for ≥ 10 years * No history of uncontrolled seizures, CNS disorders, or psychiatric disability that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy exceeding 6 weeks in duration * Prior chemotherapy given as part of neoadjuvant treatment (i.e., chemoradiotherapy) may last a maximum of 11-12 weeks * No prior oxaliplatin * Prior mitomycin C, irinotecan hydrochloride, or cetuximab allowed * No concurrent warfarin, antiviral agents, or phenytoin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (72)

Wansbeck General Hospital

Ashington, England, NE63 9JJ, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Furness General Hospital

Barrow in Furness, England, LA14 4LF, United Kingdom

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Good Hope Hospital

Birmingham, England, B75 7RR, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Pilgrim Hospital

Boston, England, PE21 9QT, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 7ET, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Princess Alexandra Hospital

Essex, England, CM20 1QX, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Royal Bolton Hospital

Farnworth, England, BL4 0JR, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

West Middlesex University Hospital

Isleworth, England, TW7 6AF, United Kingdom

Location

Kidderminster Hospital

Kidderminster Worcestershire, England, DY11 6RJ, United Kingdom

Location

Royal Albert Edward Infirmary

Lancanshire, England, WN1 2NN, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, England, LA1 4RP, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

Location

Whittington Hospital

London, England, N19 5NF, United Kingdom

Location

University College of London Hospitals

London, England, NW1 2PG, United Kingdom

Location

UCL Cancer Institute

London, England, NW1 2QG, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, England, SK10 3BL, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Hope Hospital

Salford, England, M6 8HD, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Southport and Formby District General Hospital

Southport, England, PR8 6PN, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Kingston Hospital

Surrey, England, KT2 7QB, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Royal Glamorgan Hospital

Lhantrisant, Wales, CF72 8XR, United Kingdom

Location

Hereford Hospitals

Hereford, HR1 2ER, United Kingdom

Location

Scarborough General Hospital

Scarborough, YO12 6QL, United Kingdom

Location

Related Publications (1)

• Glynne-Jones R, Counsell N, Quirke P, Mortensen N, Maraveyas A, Meadows HM, Ledermann J, Sebag-Montefiore D. Chronicle: results of a randomised phase III trial in locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant capecitabine plus oxaliplatin (XELOX) versus control. Ann Oncol. 2014 Jul;25(7):1356-1362. doi: 10.1093/annonc/mdu147. Epub 2014 Apr 8.

  PMID: 24718885 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Robert Glynne-Jones, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: November 1, 2004
• Primary Completion: March 1, 2008
• Last Updated: August 26, 2013

Record last verified: 2007-06

Locations

GB (72)