S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Detailed Description
-----------------
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy; control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29   42 days, plus cisplatin first 1  4 days and 29   33 days. Using IMRT radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1  14 days, or S-1 70 mg/m2 1  14 days, plus cisplatin 25mg/m2 1  4 days, 21 days for a cycle. Primary Outcome Measure is complete remission rate. Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.

Official Title
-----------------
Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Other: S-1 concurrent radiotherapy
* Other: S-1 plus Cisplatin concurrent radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology or cytology confirmed esophageal squamous cell carcinoma. There are measurable lesions in the RECIST standard. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a  IV B period. Age younger than 75 years old. Eastern Cooperative Oncology Group physical status score was 0   1. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before. Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L. Cr≤1.25 upper normal limit or CCr≥60 mL/min. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit. A history of interstitial pneumonia and interstitial pneumonia. FEV1>0.8 liters. Patients or family members signed a formal informed consent. Exclusion Criteria: Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia. Patients with distant metastases. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation. Can't understand the test requirements, or patients may not comply with the requirements of the test. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years. An allergic reaction known to have 3 or 4 levels of any treatment. Had participated in other clinical trials in the past 30 days. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.

Ages Eligible for Study
-----------------
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single drug<br>S-1 concurrent Radiotherapy | Other: S-1 concurrent radiotherapy<br>* Radiotherapy 60 66 Gray/28 33 times (50.4 60 Gray /28 33 planning target volume times, 60 66 Gray/28 33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1  14 days, 21 days for a cycle.<br>|
| Active Comparator: Double drug<br>S-1 plus cisplatin concurrent Radiotherapy | Other: S-1 plus Cisplatin concurrent radiotherapy<br>* Radiotherapy 60 66 Gray/28 33 times (50.4 60 Gray /28 30 planning target volume times, Gross tumor volume of primary tumor60 66 Gray/28 33), synchronous chemotherapy S-1 70 mg/m2 1  14 days and 29 to 42 days, plus cisplatin 25mg/m2 1  4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1  14 days, plus cisplatin 25mg/m2 1  4 days, 21 days for a cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission Rate (CR) | Complete response rate of primary tumor which will be measured by endoscopy and computer tomography | Three months after radiotherapy finished | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The time from treatment completion to patient death | Two years after adjuvant chemotherapy finished | 
| Progression-Free-Survival (PFS) | The time from treatment completion to disease progression | Two years after adjuvant chemotherapy finished |