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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041262 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus |
Estimated Enrollment: | 1300 |
Study Start Date: | November 2004 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the esophagus or type 1 or 2 tumors of the gastroesophageal junction
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
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 |
Study Chair: | Derek Alderson, MD | University Hospital Birmingham |
Study ID Numbers: | CDR0000069457, MRC-OE05, EU-20204 |
Study First Received: | July 8, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00041262 History of Changes |
Health Authority: | Unspecified |
stage II esophageal cancer stage III esophageal cancer adenocarcinoma of the esophagus |
Antimetabolites Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Immunosuppressive Agents Epirubicin Anti-Bacterial Agents |
Digestive System Diseases Cisplatin Esophageal Disorder Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Epirubicin Pharmacologic Actions Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases |