Selective Dose Escalation for Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer

• Registration Number: NCT00139633
• Lead Sponsor: The Oregon Clinic

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.

Study Timeline

• Study Start: 2000-07
• Study Completion: 2005-06
• Status Verified: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Last Update Submitted: 2005-08-29
• Study First Posted: 2005-08-31
• Last Update Posted: 2005-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• T1-4, N0-1, M0-1a esophageal carcinoma

Exclusion Criteria

• distant metastases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
survival at 4 years
local control at 4 years

Trial Locations

Locations (1)

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States