Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- The Oregon Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- local control at 4 years
- Last Updated
- 20 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •T1-4, N0-1, M0-1a esophageal carcinoma
Exclusion Criteria
- •distant metastases
Outcomes
Primary Outcomes
local control at 4 years
survival at 4 years