Combination Chemotherapy in Treating Patients With Esophageal Cancer
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
- Survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Local control [ Designated as safety issue: No ]
- Morbidity from surgery and chemotherapy [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 1300 |
| Study Start Date: | November 2004 |
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.
Eligibility| 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
- 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| 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 | |
| Study Chair: | Derek Alderson, MD | University Hospital Birmingham |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00041262 History of Changes |
| Other Study ID Numbers: | CDR0000069457, MRC-OE05, EU-20204 |
| Study First Received: | July 8, 2002 |
| Last Updated: | January 12, 2012 |
| Health Authority: | Unspecified |
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:
|
Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Cisplatin |
Epirubicin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013