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Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase II/III Randomized Study of Chemoradiotherapy Comprising Cisplatin, Capecitabine, and Radiotherapy With or Without Cetuximab in Patients With Carcinoma of the Esophagus
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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18 and over
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Other
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WCTU-SCOPE-1
EU-20739, EUDRACT-2006-002241-37, ISRCTN47718479, CTA-17853/0202/001-0001, NCT00509561
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Trial Description Purpose: 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.
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. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Patients in group one will receive a 2-hour infusion of cisplatin in weeks 1, 4, 7, and 10. They will also receive capecitabine by mouth twice a day for 12 weeks. Patients will undergo radiation therapy 5 days a week in weeks 7-11. Patients in group two will receive a 2-hour infusion of cisplatin in weeks 1, 4, 7, and 10 and capecitabine by mouth twice a day for 12 weeks. They will undergo radiation therapy 5 days a week in weeks 7-11. Patients will also receive a 1- to 2-hour infusion of cetuximab once a week for 12 weeks. Quality of life will be assessed at the beginning of the study, during treatment, and periodically during follow-up. After finishing treatment, patients will be evaluated every 3 months for 1 year, every 4 months for 1 year, and once a year for at least 5 years.
Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site.
Trial Contact Information
Trial Lead Organizations Wales Cancer Trials Unit | | | | Tom Crosby, MD, Protocol chair | | | |
Trial Sites
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| United Kingdom |
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| England |
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Birmingham |
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| | | | | Good Hope Hospital |
| | | John Glaholm, MD | |
| | | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust |
| | | Ian Geh, MD | |
| | Email:
ian.geh@uhb.nhs.uk |
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Bristol |
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| | | Bristol Haematology and Oncology Centre |
| | | Stephen Falk, MD | |
| | Email:
stephen.falk@ubht.nhs.uk |
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Cheltenham |
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| | | Cheltenham General Hospital |
| | | Charles Candish, MRCP, FRCR | |
| | | Gloucestershire Royal Hospital |
| | | Charles Candish, MRCP, FRCR | |
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Coventry |
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| | | Walsgrave Hospital |
| | | Sharmila Sothi | |
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Derby |
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| | | Derbyshire Royal Infirmary |
| | | Hannah Finch | | Ph: | 44-1332-347-141 ext. 2407 | | |
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Essex |
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| | | Princess Alexandra Hospital |
| | | Lucinda Melcher, MD | |
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Grimsby |
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| | | Diana Princess of Wales Hospital |
| | | Sanjay Dixit, MD | | Ph: | 44-147-287-4111 ext. 2569 | | |
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| | Email:
sanjay.dixit@nlg.nhs.uk |
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Guildford |
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| | | St. Luke's Cancer Centre at Royal Surrey County Hospital |
| | | Marianne Illsley | |
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Leeds |
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| | | Cookridge Hospital |
| | | Adrian Crellin, FRCP, FRCR | |
| | Email:
adrian.crellin@leedsth.nhs.uk |
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Leicester |
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| | | Leicester Royal Infirmary |
| | | Albert Benghiat, MD | |
| | Email:
albert.benghiat@uhl-tr.nhs.uk |
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Lincoln |
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| | | Lincoln County Hospital |
| | | Zuzana Stokes | |
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Liverpool |
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| | | Aintree University Hospital |
| | | Rajman Sripadam | |
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London |
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| | | Helen Rollason Cancer Care Centre at North Middlesex Hospital |
| | | Lucinda Melcher, MD | |
| | | Saint Bartholomew's Hospital |
| | | Amen Sibtain, MD | |
| | | UCL Cancer Institute |
| | | Astrid Mayer, MD | |
| | Email:
a.mayer@ucl.ac.uk |
| | | University College of London Hospitals |
| | | Jeffrey S. Tobias, MD | |
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Maidstone |
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| | | Maidstone Hospital |
| | | Mathilda Cominos | |
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Manchester |
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| | | Christie Hospital |
| | | Corinne Faivre-Finn, MD | |
| | Email:
corinne.finn@christie-tr.nwest.nhs.uk |
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Newcastle-Upon-Tyne |
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| | | Northern Centre for Cancer Treatment at Newcastle General Hospital |
| | | Philip Atherton | |
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Poole Dorset |
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| | | Poole Hospital NHS Trust |
| | | Virginia Laurence, MD | |
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Romford |
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| | | Queen's Hospital |
| | | Sherif Raouf, MD | |
| | Email:
sherif.raouf@bhrhospitals.nhs.uk |
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Scarborough |
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| | | Scarborough General Hospital |
| | | Chris Hamilton, MD | |
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Slough, Berkshire |
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| | | Wexham Park Hospital |
| | | Marcia Hall, MD | |
| | Email:
marcia.hall@nhs.net.uk |
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Southport |
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| | | Southport and Formby District General Hospital |
| | | Muhammed Irfan | |
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Sutton |
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| | | Royal Marsden - Surrey |
| | | David Cunningham, MD | |
| | Email:
david.cunningham@rmh.nhs.uk |
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Torquay |
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| | | Torbay Hospital |
| | | Elizabeth Toy, MD | |
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Truro, Cornwall |
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| | | Royal Cornwall Hospital |
| | | Richard Ellis | |
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Walsall |
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| | | Walsall Manor Hospital |
| | | Andrew Hartley | |
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Worcester |
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| | | Worcester Royal Hospital |
| | | Charles Candish, MRCP, FRCR | |
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| Scotland |
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Aberdeen |
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| | | | Aberdeen Royal Infirmary |
| | | Graham Macdonald, MD | |
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Dundee |
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| | | Ninewells Hospital |
| | | Douglas Adamson, MD | |
| | Email:
d.adamson@nhs.net |
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Edinburgh |
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| | | Edinburgh Cancer Centre at Western General Hospital |
| | | Hamish Phillips | |
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Glasgow |
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| | | Beatson West of Scotland Cancer Centre |
| | | Alec Mcdonald, MD | |
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| Wales |
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Cardiff |
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| | | | Velindre Cancer Center at Velindre Hospital |
| | | Tom Crosby, MD | |
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Rhyl, Denbighshire |
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| | | Glan Clwyd Hospital |
| | | Simon Gollins, MD | |
| | Email:
simon.gollins@cd-tr.wales.nhs.uk |
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Wrexham |
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| | | Wrexham Maelor Hospital |
| | | Simon Gollins, MD | |
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| Registry Information | | | Official Title | | A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus | | | Trial Start Date | | 2008-02-01 | | | Trial Completion Date | | 2010-01-01 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00509561 | | | Date Submitted to PDQ | | 2007-06-28 | | | Information Last Verified | | 2008-02-27 |
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