A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

Study Overview
=================
Brief Summary
-----------------
This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.

Official Title
-----------------
A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma

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

Intervention / Treatment
-----------------
* Drug: Huachansu
* Radiation: thoracic radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Joined the study voluntarily and signed informed consent form. Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy. Both genders. Esophageal squamous cell carcinoma confirmed by pathology. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th). No radiotherapy, chemotherapy or other treatments prior to enrollment. PS ECOG 0-2，wight loss<30% during the latest 6 months. Life expectancy of more than 3 months. Hemoglobin（Hb）≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN.Renal function: creatinine < 1.5 x ULN. No immuno-deficiency No heart diseases that need cardiac glycoside Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: Complete esophageal obstruction. Deep esophageal ulcer. Esophageal perforation. Haematemesis. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives. Drug addiction,Alcoholism or AIDS.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Huachansu Arm<br>Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy. | Drug: Huachansu<br>* Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.<br>Radiation: thoracic radiation<br>* A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.<br>|
| Active Comparator: Control Arm<br>Patients in this arm will receive thoracic radiotherapy alone. | Radiation: thoracic radiation<br>* A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | The outcome measure will be assessed by every 3-month follow-up examinations. | the date of randomization until progression inside the irradiation field, up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The survival time from date of randomization to the day of death or the last follow-up. | the date of randomization until the death or the last follow up of the patients, up to 3 years. | 
| progress-free survival | Measured from date of randomization until progression or death from any cause | the date of randomization until progression or death from any cause, up to 3 years |