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

Study Overview
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Brief Summary
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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
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Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.

Official Title
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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

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Other: Preoperative treatment of chemotherapy and radiation
* Other: Postoperative treatment of chemotherapy and radiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neoadjuvant Treatment<br>Preoperative chemotherapy/radiotherapy treatment | Other: Preoperative treatment of chemotherapy and radiation<br>* Cisplatin + 5FU with concurrent radiation followed by surgery<br>|
| Experimental: Adjuvant Treatment<br>Postoperative chemotherapy/radiotherapy treatment | Other: Postoperative treatment of chemotherapy and radiation<br>* Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed by FACT-E |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and morbidity |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy