Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
NCT ID: NCT00509561
Last Updated: 2012-12-18
Study Results
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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UNKNOWN
PHASE2/PHASE3
259 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients with esophageal cancer.
Detailed Description
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Primary
* To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus.
* To determine the safety of this regimen in these patients.
* To determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life and health economics are assessed at baseline, during treatment, and at pre-specified time points during follow-up.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then annually for a minimum of 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemo-radiotherapy
capecitabine
cisplatin
radiation therapy
Chemo-radiotherapy plus cetuximab
cetuximab
capecitabine
cisplatin
radiation therapy
Interventions
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cetuximab
capecitabine
cisplatin
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed carcinoma of the esophagus
* Adenocarcinoma
* Squamous cell
* Undifferentiated carcinoma
* Siewert type I tumor of the gastroesophageal junction
* Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and spiral CT scan
* Total disease length (primary and lymph nodes) \< 10 cm by EUS
* Not suitable for surgery (either for medical reasons or patient's choice)
* No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)
* No significant (\> 2 cm) extension of tumor into the stomach
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* White blood cell count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL (should be corrected to \> 10 g/dL before treatment)
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT/AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Glomerular filtration rate \> 40 mL/min OR \> 60 mL/min estimated by Cockcroft-Gault formula
* Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO
* FEV\_1 ≥ 1 L by spirometry
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No malignancy within the past 5 years
* No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically significant cardiac disease
* No major trauma within the past 4 weeks
* No known dihydropyrimidine dehydrogenase deficiency
* No hearing impairment or sensory-motor neuropathy \> grade 2
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior sorivudine and analogues
* At least 4 weeks since prior major surgery
* At least 4 weeks since prior monoclonal antibody
* At least 3 months since prior radiotherapy
* No prior treatment for invasive esophageal carcinoma or gastroesophageal junction carcinoma (not including photodynamic therapy or laser therapy for high-grade dysplasia/carcinoma in situ)
* No other prior treatment for this malignancy that would compromise the ability to deliver definitive mediastinal chemoradiotherapy or compromise survival
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Wales Cancer Trials Unit
OTHER
Responsible Party
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Principal Investigators
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Tom Crosby, MD
Role: STUDY_CHAIR
Velindre NHS Trust
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Gloucestershire Royal Hospital
Cheltenham, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Princess Alexandra Hospital
Essex, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, 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
Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom
Alexandra Healthcare NHS
Redditch, England, United Kingdom
Scarborough General Hospital
Scarborough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Southport and Formby District General Hospital
Southport, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Worcester Royal Hospital
Worcester, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Singleton Hospital
Swansea, Wales, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom
Countries
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Other Identifiers
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WCTU-SCOPE-1
Identifier Type: -
Identifier Source: secondary_id
EU-20739
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-002241-37
Identifier Type: -
Identifier Source: secondary_id
ISRCTN47718479
Identifier Type: -
Identifier Source: secondary_id
CTA-17853/0202/001-0001
Identifier Type: -
Identifier Source: secondary_id
CDR0000558804
Identifier Type: -
Identifier Source: org_study_id