A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma

University of Michigan Rogel Cancer Center1 site in 1 countryNovember 1997

ConditionsEsophageal Cancer

DrugsPaclitaxel Cisplatin 5-Fluorouracil

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Esophageal Cancer
Sponsor: University of Michigan Rogel Cancer Center
Locations: 1
Primary Endpoint: To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.

Registry

clinicaltrials.gov

Start Date

November 1997

End Date

July 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan Rogel Cancer Center

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
•No prior treatment allowed. No prior thoracic radiation.

Outcomes

Primary Outcomes

To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.

Secondary Outcomes

To assess the qualitative and quantitative toxicities of this regimen.
To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.