Status:
COMPLETED
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
Lead Sponsor:
Richard Malthaner
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00907543
Start Date
April 1 2009
End Date
December 31 2018
Last Update
March 6 2019
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9