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Esophageal CancerPhase 2/3NCT00509561

Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer

A Phase 2/3 study testing cetuximab, capecitabine and cisplatin in people with Esophageal Cancer, run by Wales Cancer Trials Unit at 55 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
cetuximab, capecitabine and cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
55 sitesUnited Kingdom
Study dates
Feb 2008to Sep 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United Kingdom55 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, BT8 8JR

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B12 2TH

  • Good Hope Hospital

    Birmingham, England, B75 7RR

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BE

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Gloucestershire Royal Hospital

    Cheltenham, England, GL53 7AN

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Princess Alexandra Hospital

    Essex, England, CM20 1QX

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Royal Liverpool University Hospital

    Liverpool, England, L7 8XP

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1M 6BQ

  • Helen Rollason Cancer Care Centre at North Middlesex Hospital

    London, England, N18 1QX

  • University College of London Hospitals

    London, England, WIT 3AA

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Dorset Cancer Centre

    Poole Dorset, England, BH15 2JB

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Alexandra Healthcare NHS

    Redditch, England, B98 7UB

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Scarborough General Hospital

    Scarborough, England, YO12 6QL

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Southport and Formby District General Hospital

    Southport, England, PR8 6PN

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital

    Swansea, Wales, SA2 8QA

  • Musgrove Park Hospital

    Taunton, England, TA1 5DA

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, Cornwall, England, TR1 3LJ

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

  • Wrexham Maelor Hospital

    Wrexham, Wales, LL13 7TD

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
cetuximab, capecitabine, cisplatin, radiation therapy
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage IA esophageal cancer, stage IB esophageal cancer, stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00509561
Study groupRoleWhat they receive
Chemo-radiotherapyActive comparatorNot described
Receives: Drug: capecitabine; Drug: cisplatin; Radiation: radiation therapy
Chemo-radiotherapy plus cetuximabExperimentalNot described
Receives: Biological: cetuximab; Drug: capecitabine; Drug: cisplatin; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-failure rate at 24 weeks

  2. Overall survival

Secondary outcomes (5)

  1. Feasibility

  2. Toxicity

  3. Quality of life

  4. Quality of assurance

  5. Health economics

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509561
Sponsor's protocol ID
CDR0000558804
Other IDs
WCTU-SCOPE-1, EU-20739, EUDRACT-2006-002241-37, ISRCTN47718479, CTA-17853/0202/001-0001
Status last verified
Dec 2012
First submitted
30 Jul 2007
Last updated
18 Dec 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing cetuximab, capecitabine and cisplatin in people with Esophageal Cancer, run by Wales Cancer Trials Unit at 55 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-failure rate at 24 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.

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