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Phase II/III Randomized Study of Chemoradiotherapy Comprising Cisplatin, Capecitabine, and Radiotherapy With or Without Cetuximab in Patients With Carcinoma of the Esophagus
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
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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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.
Entry Criteria 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
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
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
- FEV1 ≥ 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
Expected Enrollment 420Outcomes Primary Outcome(s)Treatment-failure rate at 24 weeks Overall survival
Secondary Outcome(s)Feasibility Toxicity Quality of life Quality of assurance Health economics
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.
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 | | 2008-12-21 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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