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NCT00427713

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

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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capecitabine

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

standard follow-up care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Robert Glynne-Jones, MD

Role: STUDY_CHAIR

Mount Vernon Cancer Centre at Mount Vernon Hospital

Locations

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Wansbeck General Hospital

Ashington, England, United Kingdom

Site Status

North Devon District Hospital

Barnstaple, England, United Kingdom

Site Status

Furness General Hospital

Barrow in Furness, England, United Kingdom

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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

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Good Hope Hospital

Birmingham, England, United Kingdom

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Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

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Blackpool Victoria Hospital

Blackpool, England, United Kingdom

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Pilgrim Hospital

Boston, England, United Kingdom

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Queen's Hospital

Burton-on-Trent, England, United Kingdom

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Cumberland Infirmary

Carlisle, England, United Kingdom

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Broomfield Hospital

Chelmsford, Essex, England, United Kingdom

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Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, United Kingdom

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Castle Hill Hospital

Cottingham, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Doncaster Royal Infirmary

Doncaster, England, United Kingdom

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University Hospital of North Durham

Durham, England, United Kingdom

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Princess Alexandra Hospital

Essex, England, United Kingdom

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Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

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Royal Bolton Hospital

Farnworth, England, United Kingdom

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Queen Elizabeth Hospital

Gateshead, England, United Kingdom

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Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

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

Guildford, England, United Kingdom

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Wycombe General Hospital

High Wycombe, England, United Kingdom

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Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, United Kingdom

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King George Hospital

Ilford, Essex, England, United Kingdom

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Ipswich Hospital

Ipswich, England, United Kingdom

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West Middlesex University Hospital

Isleworth, England, United Kingdom

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Kidderminster Hospital

Kidderminster Worcestershire, England, United Kingdom

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Royal Albert Edward Infirmary

Lancanshire, England, United Kingdom

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Royal Lancaster Infirmary

Lancaster, England, United Kingdom

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Cookridge Hospital

Leeds, England, United Kingdom

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Lincoln County Hospital

Lincoln, England, United Kingdom

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