Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer
- Determine the complete pathologic response (complete response [CR]) rate in patients
with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine,
- Determine the clinical efficacy and toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
- Identify basal expression and changes in gene expression that relate to CR, relapse,
and survival of patients treated with this regimen.
- Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1,
15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12,
15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on
the same days they undergo radiotherapy.
- Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who
are eligible undergo esophagectomy.
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin
IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on
days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for
up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene
expression studies, microarray analysis, and real-time quantitative reverse
transcriptase-PCR to identify basal expression and changes in gene expression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nikhil Khushalani, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|