Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title: Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

• NCT number: NCT00137852
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: September 2017