Combination Chemotherapy in Treating Patients With Esophageal Cancer

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ClinicalTrials.gov 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

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

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:

OBJECTIVES:

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.

Study Design

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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

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Survival

Secondary Outcome Measures :

Disease-free survival
Local control
Morbidity from surgery and chemotherapy
Quality of life

Eligibility Criteria

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

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

WHO 0-1

Life expectancy:

Not specified

Hematopoietic:

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

Hepatic:

Liver function tests no greater than 1.5 times normal

Renal:

Glomerular filtration rate greater than 60 mL/min

Cardiovascular:

Ejection fraction greater than 50% OR
Normal echocardiograph

Pulmonary:

FEV1 greater than 1.5 L

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

See Disease Characteristics

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00041262

Locations

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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 d.alderson@bham.ac.uk

Sponsors and Collaborators

Medical Research Council

Investigators

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Study Chair:	Derek Alderson, MD	University Hospital Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alderson D, Cunningham D, Nankivell M, Blazeby JM, Griffin SM, Crellin A, Grabsch HI, Langer R, Pritchard S, Okines A, Krysztopik R, Coxon F, Thompson J, Falk S, Robb C, Stenning S, Langley RE. Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1249-1260. doi: 10.1016/S1470-2045(17)30447-3. Epub 2017 Aug 4.

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ClinicalTrials.gov Identifier:	NCT00041262
Other Study ID Numbers:	MRC-OE05 CDR0000069457 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20204
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 Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Fluorouracil Epirubicin	Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors

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