Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate.
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer|
- Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma [ Time Frame: TBD ] [ Designated as safety issue: No ]
- Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||January 2013|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137852
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Peter C. Enzinger, MD||Dana-Farber Cancer Institute|