Esophageal Neoplasms
Conditions
Keywords
esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy
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.
Interventions
OTHERPreoperative treatment of chemotherapy and radiation
Cisplatin + 5FU with concurrent radiation followed by surgery
OTHERPostoperative treatment of chemotherapy and radiation
Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation
Sponsors
Richard Malthaner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life as assessed by FACT-E | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Safety and morbidity | 1 year |
Countries
Canada
Outcome results
None listed