- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00509561
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus
RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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England
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Birmingham, England, United Kingdom, B75 7RR
- Good Hope Hospital
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Birmingham, England, United Kingdom, B12 2TH
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
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Brighton, England, United Kingdom, BN2 5BE
- Sussex Cancer Centre at Royal Sussex County Hospital
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Bristol, England, United Kingdom, BS2 8ED
- Bristol Haematology and Oncology Centre
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Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
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Carlisle, England, United Kingdom, CA2 7HY
- Cumberland Infirmary
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Cheltenham, England, United Kingdom, GL53 7AN
- Gloucestershire Oncology Centre at Cheltenham General Hospital
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Cheltenham, England, United Kingdom, GL53 7AN
- Gloucestershire Royal Hospital
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Coventry, England, United Kingdom, CV2 2DX
- Walsgrave Hospital
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Doncaster, England, United Kingdom, DN2 5LT
- Doncaster Royal Infirmary
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Essex, England, United Kingdom, CM20 1QX
- Princess Alexandra Hospital
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Exeter, England, United Kingdom, EX2 5DW
- Royal Devon and Exeter Hospital
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Grimsby, England, United Kingdom, DN33 2BA
- Diana Princess of Wales Hospital
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Guildford, England, United Kingdom, GU2 7XX
- St. Luke's Cancer Centre at Royal Surrey County Hospital
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Hull, England, United Kingdom, HU8 9HE
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
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Leeds, England, United Kingdom, LS16 6QB
- Cookridge Hospital
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Leicester, England, United Kingdom, LE1 5WW
- Leicester Royal Infirmary
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Lincoln, England, United Kingdom, LN2 5QY
- Lincoln County Hospital
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Liverpool, England, United Kingdom, L9 7AL
- Aintree University Hospital
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Liverpool, England, United Kingdom, L7 8XP
- Royal Liverpool University Hospital
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London, England, United Kingdom, WIT 3AA
- University College of London Hospitals
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London, England, United Kingdom, N18 1QX
- Helen Rollason Cancer Care Centre at North Middlesex Hospital
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London, England, United Kingdom, EC1M 6BQ
- Saint Bartholomew's Hospital
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Maidstone, England, United Kingdom, ME16 9QQ
- Maidstone Hospital
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Manchester, England, United Kingdom, M20 4BX
- Christie Hospital
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Merseyside, England, United Kingdom, CH63 4JY
- Clatterbridge Centre for Oncology
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Middlesbrough, England, United Kingdom, TS4 3BW
- James Cook University Hospital
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Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
- Northern Centre for Cancer Treatment at Newcastle General Hospital
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Northwood, England, United Kingdom, HA6 2RN
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital
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Peterborough, England, United Kingdom, PE3 6DA
- Peterborough Hospitals Trust
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Plymouth, England, United Kingdom, PL6 8DH
- Derriford Hospital
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Poole Dorset, England, United Kingdom, BH15 2JB
- Dorset Cancer Centre
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Portsmouth Hants, England, United Kingdom, PO3 6AD
- Portsmouth Oncology Centre at Saint Mary's Hospital
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Redditch, England, United Kingdom, B98 7UB
- Alexandra Healthcare NHS
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Scarborough, England, United Kingdom, YO12 6QL
- Scarborough General Hospital
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Sheffield, England, United Kingdom, S1O 2SJ
- Cancer Research Centre at Weston Park Hospital
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Slough, Berkshire, England, United Kingdom, SL2 4HL
- Wexham Park Hospital
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Southport, England, United Kingdom, PR8 6PN
- Southport and Formby District General Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden - Surrey
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Taunton, England, United Kingdom, TA1 5DA
- Musgrove Park Hospital
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Torquay, England, United Kingdom, TQ2 7AA
- Torbay Hospital
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Truro, Cornwall, England, United Kingdom, TR1 3LJ
- Royal Cornwall Hospital
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Worcester, England, United Kingdom, WR5 1DD
- Worcester Royal Hospital
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT8 8JR
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
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Dundee, Scotland, United Kingdom, DD1 9SY
- Ninewells Hospital
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Edinburgh, Scotland, United Kingdom, EH4 2XU
- Edinburgh Cancer Centre at Western General Hospital
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Glasgow, Scotland, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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Inverness, Scotland, United Kingdom, 1V2 3UJ
- Raigmore Hospital
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Wales
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Cardiff, Wales, United Kingdom, CF14 2TL
- Velindre Cancer Center at Velindre Hospital
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Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
- Glan Clwyd Hospital
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Swansea, Wales, United Kingdom, SA2 8QA
- Singleton Hospital
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Wrexham, Wales, United Kingdom, LL13 7TD
- Wrexham Maelor Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Chemo-radiotherapy
|
|
EXPERIMENTAL: Chemo-radiotherapy plus cetuximab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall survival
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Treatment-failure rate at 24 weeks
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Secondary Outcome Measures
Outcome Measure |
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Toxicity
|
Quality of life
|
Health economics
|
Feasibility
|
Quality of assurance
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Tom Crosby, MD, Velindre NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Cisplatin
- Capecitabine
- Cetuximab
Other Study ID Numbers
- CDR0000558804
- WCTU-SCOPE-1
- EU-20739
- EUDRACT-2006-002241-37
- ISRCTN47718479
- CTA-17853/0202/001-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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