A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
- Determine the pathologic complete response in patients with adenocarcinoma of the
esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising
capecitabine, oxaliplatin, and radiotherapy.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the recurrence rate, time to progression, and patterns of failure in patients
treated with this regimen.
- Characterize the toxicity profile of this regimen in these patients.
- Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and
oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity.
- Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once
weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and
undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease
progression or unacceptable toxicity.
- Surgery: Patients undergo surgical resection at 4-8 weeks after completion of
After completion of study treatment, patients are followed every 3 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response
At time of surgery
Mary Mulcahy, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|