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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509561
Recruitment Status : Unknown
Verified December 2012 by Wales Cancer Trials Unit.
Recruitment status was:  Active, not recruiting
First Posted : July 31, 2007
Last Update Posted : December 18, 2012
Cancer Research UK
Information provided by (Responsible Party):
Wales Cancer Trials Unit

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Biological: cetuximab Drug: capecitabine Drug: cisplatin Radiation: radiation therapy Phase 2 Phase 3

Detailed Description:



  • 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 : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus
Study Start Date : February 2008
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Active Comparator: Chemo-radiotherapy Drug: capecitabine
Drug: cisplatin
Radiation: radiation therapy
Experimental: Chemo-radiotherapy plus cetuximab Biological: cetuximab
Drug: capecitabine
Drug: cisplatin
Radiation: radiation therapy

Primary Outcome Measures :
  1. Treatment-failure rate at 24 weeks
  2. Overall survival

Secondary Outcome Measures :
  1. Feasibility
  2. Toxicity
  3. Quality of life
  4. Quality of assurance
  5. Health economics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509561

  Show 55 Study Locations
Sponsors and Collaborators
Wales Cancer Trials Unit
Cancer Research UK
Study Chair: Tom Crosby, MD Velindre NHS Trust

Responsible Party: Wales Cancer Trials Unit Identifier: NCT00509561     History of Changes
Other Study ID Numbers: CDR0000558804
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Wales Cancer Trials Unit:
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action