Prospective Randomized Phase III Trial Comparing Preoperative Chemoradiation Therapy (Cisplatin, 5-FU and Radiotherapy Followed by Surgery) to Surgery Followed by Postoperative Chemoradiation (Cisplatin, Epirubicin, 5-FU, Radiotherapy) for Esophageal Cancer

Richard Malthaner1 site in 1 country96 target enrollmentApril 2009

ConditionsEsophageal Neoplasms

Overview

Phase: N/A
Intervention: Not specified
Conditions: Esophageal Neoplasms
Sponsor: Richard Malthaner
Enrollment: 96
Locations: 1
Primary Endpoint: Quality of life as assessed by FACT-E
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

Detailed Description

Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

December 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Richard Malthaner

Responsible Party

Sponsor Investigator

Principal Investigator

Richard Malthaner

Sponsor-Investigator

Lawson Health Research Institute

Eligibility Criteria

Inclusion Criteria

•Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20 cm from the incisors) or gastroesophageal junction are included.
•No distant metastases (M0).
•Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
•Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
•Resectable mediastinal nodes are eligible.
•No prior chemotherapy for this malignancy.
•No prior radiotherapy that would overlap the field(s) treated in this study.
•Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
•Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion Criteria

•Cancers of the cervical esophagus (\< 20 cm are excluded).
•Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
•Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
•Patients with biopsy proven metastatic celiac nodes are ineligible.