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Colorectal CancerPhase 3NCT00427713

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

A Phase 3 study testing capecitabine, oxaliplatin and adjuvant therapy in people with Colorectal Cancer, run by Cancer Research UK at 72 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine, oxaliplatin and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
800 participants
Where
72 sitesUnited Kingdom
Study dates
Nov 2004to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United Kingdom72 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Wansbeck General Hospital

    Ashington, England, NE63 9JJ

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Furness General Hospital

    Barrow in Furness, England, LA14 4LF

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Good Hope Hospital

    Birmingham, England, B75 7RR

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Pilgrim Hospital

    Boston, England, PE21 9QT

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Broomfield Hospital

    Chelmsford, Essex, England, CM1 7ET

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Castle Hill Hospital

    Cottingham, England, HU16 5JQ

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • University Hospital of North Durham

    Durham, England, DH1 5TW

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Princess Alexandra Hospital

    Essex, England, CM20 1QX

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Royal Bolton Hospital

    Farnworth, England, BL4 0JR

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G11 6NT

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

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

    Guildford, England, GU2 7XX

  • Hereford Hospitals

    Hereford, HR1 2ER

  • Wycombe General Hospital

    High Wycombe, England

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • King George Hospital

    Ilford, Essex, England, IG3 8YB

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • West Middlesex University Hospital

    Isleworth, England, TW7 6AF

  • Kidderminster Hospital

    Kidderminster Worcestershire, England, DY11 6RJ

  • Royal Albert Edward Infirmary

    Lancanshire, England, WN1 2NN

  • Royal Lancaster Infirmary

    Lancaster, England, LA1 4RP

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • Royal Glamorgan Hospital

    Lhantrisant, Wales, CF72 8XR

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Helen Rollason Cancer Care Centre at North Middlesex Hospital

    London, England, N18 1QX

  • Whittington Hospital

    London, England, N19 5NF

  • University College of London Hospitals

    London, England, NW1 2PG

  • UCL Cancer Institute

    London, England, NW1 2QG

  • St. George's Hospital

    London, England, SW17 0QT

  • Charing Cross Hospital

    London, England, W6 8RF

  • Macclesfield District General Hospital

    Macclesfield, England, SK10 3BL

  • Christie Hospital

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • St. Mary's Hospital

    Newport, England, PO30 5TG

  • Northampton General Hospital

    Northampton, England, NN1 5BD

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Churchill Hospital

    Oxford, England, OX3 7LJ

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Hope Hospital

    Salford, England, M6 8HD

  • Scarborough General Hospital

    Scarborough, YO12 6QL

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S10 2SJ

  • Royal Shrewsbury Hospital

    Shrewsbury, England, SY3 8XQ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Southport and Formby District General Hospital

    Southport, England, PR8 6PN

  • Sunderland Royal Hospital

    Sunderland, England, SR4 7TP

  • Kingston Hospital

    Surrey, England, KT2 7QB

  • Walsall Manor Hospital

    Walsall, England, WS2 9PS

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

Other trials in United Kingdom

About this study

Official 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 [CHRONICLE]

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.

Read the 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.

Being tested
capecitabine, oxaliplatin, adjuvant therapy, standard follow-up care
Keywords
adenocarcinoma of the rectum, stage III rectal cancer, stage II rectal cancer
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival at 3 years

Secondary outcomes (2)

  1. Overall survival at 5 years

  2. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2007 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00427713
Sponsor's protocol ID
CDR0000526299
Other IDs
CRUK-CHRONICLE, CRUK-BRD/05/132, EU-20679, ISRCTN59865116, CTA21106/0016/001, EUDRACT-2004-001484-21
Status last verified
Jun 2007
First submitted
25 Jan 2007
Last updated
26 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 24718885

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, oxaliplatin and adjuvant therapy in people with Colorectal Cancer, run by Cancer Research UK at 72 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival at 3 years. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427713, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.

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