Esophageal Cancer Clinical Trial
Official title:
A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus
Verified date | March 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 1300 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Birmingham | England |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | No | ||
Secondary | Disease-free survival | No | ||
Secondary | Local control | No | ||
Secondary | Morbidity from surgery and chemotherapy | No | ||
Secondary | Quality of life | No |
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