Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatment carboplatin, 5fu, taxol and radiation
Phase phase 2
Sponsor The Oregon Clinic
Collaborator Bristol-Myers Squibb
Start date July 2000
End date June 2005
Trial size 25 participants
Trial identifier NCT00139633, ETH097-02D

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
survival at 4 years
time frame:
local control at 4 years
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - T1–4, N0–1, M0–1a esophageal carcinoma Exclusion Criteria: - distant metastases

Additional Information

Official title Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2005.
Information provided to ClinicalTrials.gov by The Oregon Clinic.