Status and phase
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About
RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of docetaxel.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Approximately 7 days after completion of induction therapy, patients proceed to chemoradiotherapy.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed esophageal or gastroesophageal junction cancer
Locally advanced disease, meeting 1 of the following staging criteria:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin normal
Meets 1 of the following criteria:
Renal
Cardiovascular
Gastrointestinal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Other
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Data sourced from clinicaltrials.gov
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