Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.

Detailed Description
-----------------
Patient Population: Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0 Scheme: Patients are randomized to 2 arms: Arm A: Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles. Arm B: Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.

Official Title
-----------------
Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: Neoadjuvant chemoradiotherapy
* Other: Adjuvant chemoradiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included. No distant metastases (M0). Patients will be stratified by stage (clinical N0 versus clinical N1). 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant Treatment<br>Preoperative chemotherapy/radiotherapy | Other: Neoadjuvant chemoradiotherapy<br>* Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.<br>* Other names: Neoadjuvant Treatment;|
| Experimental: Adjuvant Treatment<br>Postoperative chemotherapy/radiotherapy | Other: Adjuvant chemoradiotherapy<br>* Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.<br>* Other names: Adjuvant Treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of Quality of life | Assess the quality of life based on FACT-E. | 1 year | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Assess the safety and tolerability based on NCI CTC V4.0 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival | Three years disease free survival will be evaluated. | 3 years | 
| Overall Survival | Three years overall survival will be evaluated. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy