Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

Not Applicable

Completed

• Conditions: Esophageal Neoplasms
• Interventions: Other: Preoperative treatment of chemotherapy and radiation; Other: Postoperative treatment of chemotherapy and radiation

• Registration Number: NCT00907543
• Lead Sponsor: Richard Malthaner

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Treatment	Preoperative treatment of chemotherapy and radiation	Preoperative chemotherapy/radiotherapy treatment
Adjuvant Treatment	Postoperative treatment of chemotherapy and radiation	Postoperative chemotherapy/radiotherapy treatment

Primary Outcome Measures

Name	Time	Method
Quality of life as assessed by FACT-E	1 year

Secondary Outcome Measures

Name	Time	Method
Safety and morbidity	1 year

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada