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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	18 and over	Other	WCTU-SCOPE-1 EU-20739, EUDRACT-2006-002241-37, ISRCTN47718479, CTA-17853/0202/001-0001, NCT00509561

Objectives

Primary

1. 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.
2. To determine the safety of this regimen in these patients.
3. 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

Outcomes

Treatment-failure rate at 24 weeks
Overall survival

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		Ph: 44-29-2031-6292

United Kingdom
England
	Birmingham
	Good Hope Hospital
		John Glaholm, MD	Ph:  44-121-627-2443
	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
		Ian Geh, MD	Ph:  44-121-472-1311
			Email: ian.geh@uhb.nhs.uk
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Contact Person	Ph:  44-12-7369-6955
			Email: angus.robinson@bsuh.nhs.uk
	Bristol
	Bristol Haematology and Oncology Centre
		Stephen Falk, MD	Ph:  44-117-928-3074
			Email: stephen.falk@ubht.nhs.uk
	Cambridge
	Addenbrooke's Hospital
		Contact Person	Ph:  44-1223-216-555
			Email: catherine.jephcott@addenbrookes.nhs.uk
	Carlisle
	Cumberland Infirmary
		Contact Person	Ph:  44-1228-814-688
			Email: jonathon.nicoll@ncumbria-acute.nhs.uk
	Cheltenham
	Cheltenham General Hospital
		Charles Candish, MRCP, FRCR	Ph:  44-8454-224-925
	Gloucestershire Royal Hospital
		Charles Candish, MRCP, FRCR	Ph:  44-8454-224-925
	Coventry
	Walsgrave Hospital
		Sharmila Sothi	Ph:  44-24-7660-2020
	Derby
	Derbyshire Royal Infirmary
		R. B. Kulkarni, MD	Ph:  44-1332-347-141 ext. 4562
	Essex
	Princess Alexandra Hospital
		Lucinda Melcher, MD	Ph:  44-1279-694-920
	Exeter
	Royal Devon and Exeter Hospital
		Contact Person	Ph:  44-1392-402-104
			Email: liz@rdeft.nhs.uk
	Grimsby
	Diana Princess of Wales Hospital
		Sanjay Dixit, MD	Ph:  44-147-287-4111 ext. 2569
			Email: sanjay.dixit@nlg.nhs.uk
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Marianne Illsley	Ph:  44-1483-571-122
	Hull
	Princess Royal Hospital at Hull and East Yorkshire NHS Trust
		Contact Person	Ph:  44-1482-701-151
	Leeds
	Cookridge Hospital
		Adrian Crellin, FRCP, FRCR	Ph:  44-113-392-4475
			Email: adrian.crellin@leedsth.nhs.uk
	Leicester
	Leicester Royal Infirmary
		Albert Benghiat, MD	Ph:  44-116-258-5081
			Email: albert.benghiat@uhl-tr.nhs.uk
	Lincoln
	Lincoln County Hospital
		Zuzana Stokes	Ph:  44-1522-512-512
	Liverpool
	Aintree University Hospital
		Rajman Sripadam	Ph:  44-151-525-5980
	Royal Liverpool University Hospital
		Contact Person	Ph:  44-151-334-115-51
			Email: nicki.thorp@ccotrust.nhs.uk
	London
	Helen Rollason Cancer Care Centre at North Middlesex Hospital
		Lucinda Melcher, MD	Ph:  44-20-8887-2000
	Saint Bartholomew's Hospital
		Amen Sibtain, MD	Ph:  44-20-7601-8353
	University College of London Hospitals
		Contact Person	Ph:  44-20-7636-8333
	Maidstone
	Maidstone Hospital
		Mathilda Cominos	Ph:  44-1622-729-000
	Manchester
	Christie Hospital
		Contact Person	Ph:  44-845-226-3000
	Merseyside
	Clatterbridge Centre for Oncology
		Contact Person	Ph:  44-151-334-1155
			Email: brian.haylock@ccotrust.nhs.uk
	Middlesbrough
	James Cook University Hospital
		Contact Person	Ph:  44-1642-854-912
			Email: nick.wadd@stees.nhs.uk
	Newcastle-Upon-Tyne
	Northern Centre for Cancer Treatment at Newcastle General Hospital
		Philip Atherton	Ph:  44-191-219-4200
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-1923-844-398
			Email: markharrison@nhs.net
	Nottingham
	Nottingham City Hospital NHS Trust
		Contact Person	Ph:  44-115-969-1169
			Email: eric.bessell@muh.nhs.uk
	Peterborough
	Peterborough Hospitals Trust
		Contact Person	Ph:  44-1733-875-5500
			Email: catherine.jephcott@pbh-tr.nhs.uk
	Poole Dorset
	Poole Hospital NHS Trust
		Virginia Laurence, MD	Ph:  44-1202-448-263
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Contact Person	Ph:  44-23-9228-6000
			Email: kudingila.madhava@porthosp.nhs.uk
	Redditch
	Alexandra Healthcare NHS
		Contact Person	Ph:  44-2476-967-483
			Email: sharmila.sothi@uhcw.nhs.uk
	Romford
	Queen's Hospital
		Sherif Raouf, MD	Ph:  44-1708-435-435
			Email: sherif.raouf@bhrhospitals.nhs.uk
	Scarborough
	Scarborough General Hospital
		Chris Hamilton, MD	Ph:  44-1723-368-111
	Slough, Berkshire
	Wexham Park Hospital
		Marcia Hall, MD	Ph:  44-1753-634-364
			Email: marcia.hall@nhs.net.uk
	Southampton
	Southampton General Hospital
		Contact Person	Ph:  44-23-8079-5168
			Email: arb@soton.ac.uk
	Southport
	Southport and Formby District General Hospital
		Sun Myint, MD, FRCP(Edin), DMRT, FFRCS, FRCP	Ph:  44-1704-547-471
	Sutton
	Royal Marsden - Surrey
		David Cunningham, MD	Ph:  44-20-8661-3279
			Email: david.cunningham@rmh.nhs.uk
	Torquay
	Torbay Hospital
		Elizabeth Toy, MD	Ph:  44-1803-614-567
	Truro, Cornwall
	Royal Cornwall Hospital
		Richard Ellis	Ph:  44-1872-250-000
	Worcester
	Worcester Royal Hospital
		Charles Candish, MRCP, FRCR	Ph:  44-1905-763-333
Northern Ireland
	Belfast
	Belfast City Hospital Trust Incorporating Belvoir Park Hospital
		Contact Person	Ph:  44-2890-699-069
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Graham Macdonald, MD	Ph:  44-845-456-6000
	Dundee
	Ninewells Hospital
		Douglas Adamson, MD	Ph:  44-1382-632-388
			Email: d.adamson@nhs.net
	Edinburgh
	Edinburgh Cancer Centre at Western General Hospital
		Hamish Phillips	Ph:  44-131-537-1000
	Glasgow
	Beatson West of Scotland Cancer Centre
		Alec Mcdonald, MD	Ph:  44-141-301-7070
	Inverness
	Raigmore Hospital
		Contact Person	Ph:  44-1463-704-309
			Email: david.whillis@nhs.net
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Tom Crosby, MD	Ph:  44-29-2031-6292
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Simon Gollins, MD	Ph:  44-1745-583-910
			Email: simon.gollins@cd-tr.wales.nhs.uk
	Swansea
	Singleton Hospital
		Contact Person	Ph:  44-1792-285-283
			Email: colin.askill@swansea-tr-wales.nhs.uk
	Wrexham
	Wrexham Maelor Hospital
		Simon Gollins, MD	Ph:  44-1978-291-100

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		2009-01-25