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
18 Years
N/A
Both
Esophageal Neoplasms
Trial Information
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
Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life
questionnaires will be completed every 2 months up to 1 year.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Quality of life as assessed by FACT-E
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Richard Malthaner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
London Health Sciences Centre
Authority:
Canada: Ethics Review Committee
Study ID:
R-09-025
NCT ID:
NCT00907543
Start Date:
April 2009
Completion Date:
April 2017
Related Keywords:
- Esophageal Neoplasms
- esophageal carcinoma
- chemotherapy
- radiation
- surgery
- randomized clinical trial
- Clinical Trial
- Radiotherapy
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
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