Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Combination Chemotherapy in Treating Patients With Esophageal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2002
Last updated: August 9, 2013
Last verified: March 2007

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 Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • Disease-free survival
  • Local control
  • Morbidity from surgery and chemotherapy
  • Quality of life

Estimated Enrollment: 1300
Study Start Date: November 2004
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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00041262

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
Study Chair: Derek Alderson, MD University Hospital Birmingham
  More Information Identifier: NCT00041262     History of Changes
Other Study ID Numbers: MRC-OE05
CDR0000069457 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: July 8, 2002
Last Updated: August 9, 2013

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:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 24, 2017