Combination Chemotherapy in Treating Patients With Esophageal Cancer (NCT00041262) | Clinical Trial Compass
UnknownPhase 3
Combination Chemotherapy in Treating Patients With Esophageal Cancer
United Kingdom1,300 participantsStarted 2004-11
Plain-language 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.
Who can participate
SexALL
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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