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Combination Chemotherapy 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: NCT00041262
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 3

Detailed Description:


  • Compare survival and quality of life of patients with resectable adenocarcinoma of the esophagus treated prior to surgery with standard chemotherapy comprising cisplatin and fluorouracil versus prolonged infusional chemotherapy comprising cisplatin, epirubicin, and fluorouracil.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

  • Arm I (Standard chemotherapy): Patients receive cisplatin IV over 4 hours on days 1-4 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (Infusional chemotherapy): Patients receive cisplatin IV over 4 hours on day 1, epirubicin IV on day 1, and fluorouracil IV continuously. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery 4-6 weeks after the last dose of fluorouracil in arm I or anytime after the fluorouracil infusion is completed in arm II.

Quality of life is assessed at baseline, immediately before starting the last course of chemotherapy, immediately before surgery, 6 weeks post-operatively, and at 6, 9, 12, 18, and 24 months after randomization.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 1,300 patients (650 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Disease-free survival
  2. Local control
  3. Morbidity from surgery and chemotherapy
  4. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the esophagus or type 1 or 2 tumors of the gastroesophageal junction

    • Stage IIB or greater by spiral or multi-slice CT scan and endoscopic ultrasound
    • Amenable to primary surgery with curative intent
  • No para-aortic/celiac lymphadenopathy greater than 1 cm on CT scan and/or greater than 6 mm on endoscopic ultrasound
  • No disease invading the airways, aorta, pericardium, or lung
  • No liver, lung, or other distant metastases



  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3


  • Liver function tests no greater than 1.5 times normal


  • Glomerular filtration rate greater than 60 mL/min


  • Ejection fraction greater than 50% OR
  • Normal echocardiograph


  • FEV1 greater than 1.5 L


  • Not pregnant or nursing
  • No prior primary malignancy
  • No significant medical condition that would preclude study


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics

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): NCT00041262

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United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Derek Alderson, MD    44-121-627-2276   
Sponsors and Collaborators
Medical Research Council
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Study Chair: Derek Alderson, MD University Hospital Birmingham

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00041262     History of Changes
Other Study ID Numbers: MRC-OE05
CDR0000069457 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: March 2007
Keywords provided by National Cancer Institute (NCI):
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
adenocarcinoma of the esophagus
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors