Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
Conditions
Esophageal Neoplasms
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Preoperative treatment of chemotherapy and radiation Type: Other
Name: Postoperative treatment of chemotherapy and radiation Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
London Health Sciences Centre
London, Ontario, Canada
Status: Recruiting
Contact: Richard Malthaner, MD - 519-667-6835 - richard.malthaner@lhsc.on.ca
Start Date
April 2009
Completion Date
April 2017
Sponsors
Lawson Health Research Institute
Source
Lawson Health Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page