A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.

Detailed Description
-----------------
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only

Official Title
-----------------
A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma

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

Intervention / Treatment
-----------------
* Radiation: Adjuvant radiotherapy
* Radiation: Adjuvant radiotherapy
* Drug: Paclitaxel and carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ; Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy); The expectation of life is more than 6 months; Age: 18 70 years old; Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function); ECOG (Eastern Cooperative Oncology Group) : 0-1; Able to understand this study and have signed informed consent. Exclusion Criteria: Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery; Known or suspected of allergy to paclitaxel or carboplatin; Female in pregnancy or lactating; With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent; Patients with peripheral neuropathy(CTC grade≥2); With other malignant tumors before the recruitment. The researchers consider that the patient is not appropriate to enroll the study; The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: adjuvant chemoradiotherapy<br>Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. | Radiation: Adjuvant radiotherapy<br>* Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.<br>Drug: Paclitaxel and carboplatin<br> <br> |
| Experimental: adjuvant radiotherapy<br>Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. | Radiation: Adjuvant radiotherapy<br>* adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall survival | To evaluate the 3 years overall survival of two groups. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | To evaluate the 3 years disease-free survival of two groups. | 3 years | 
| Adverse Events | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0 | 1 year | 
| Scores of Quality of life | Assess the quality of life based on FACT-E | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy