NCT00139633

Selective Dose Escalation for Esophageal Cancer

Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: The Oregon Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

Detailed description

we prospectively enrolled patients with T1-4, N0-1, M0-1a esophageal carcinoma to receive paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8, 15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1-38. RT was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6-8 weeks, patients underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS), and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months with CT/EUS first year, every 6 months thereafter.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	carboplatin, 5FU, Taxol and radiation

Timeline

• Start date: 2000-07-01
• Completion: 2005-06-01
• First posted: 2005-08-31
• Last updated: 2005-08-31

Locations

1 site across 1 country: United States