Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
Patients will take celecoxib orally twice daily 3 days prior to radiation therapy and until
one week prior to surgery. Celecoxib will then be restarted when the patient is discharged
from the hospital following surgery and continued for 26 weeks.
Patients will receive chemotherapy (cisplatin and irinotecan) weekly on weeks 1, 2, 4 and 5
during radiation therapy. Chemotherapy must occur on or before the fifth day of radiation
therapy.
Radiation therapy will be performed 5 days a week over a 5.6 week period.
Patients will undergo an esophagectomy within 4-8 weeks of chemotherapy/radiation therapy.
Technically accessible lymph nodes will also be removed.
During chemotherapy/radiation therapy, a physical exam and bloodwork will be conducted
weekly.
Between chemotherapy/radiation therapy and surgery a physical exam, bloodwork and CT of
chest, abdomen, and pelvis should be performed.
After the completion of treatment and surgery, a physical exam and bloodwork should be done
every 6 weeks for 6 months, then every 3 months for 1 1/2 years, then every 6 months for 3
years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma
TBD
No
Peter C. Enzinger, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
01-229
NCT00137852
January 2002
January 2013
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |