Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Official Title
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Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

Conditions
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Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Radiation Therapy, Postoperative

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Carboplatin
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Joined the study voluntarily and signed informed consent form; Age 18-75; ECOG 0-2; Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection; The operative incision healed well; T3-4N0M0, T1-4N1-3M0 (according to AJCC2009); No radiotherapy, chemotherapy or other treatments pre (post) surgery; PS ECOG 0-2; Life expectancy of more than 3 months; Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 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; Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis; Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; Participation in other interventional clinical trials within 30 days; Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; Drug addiction, Alcoholism or AIDS; Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; Unsuitable to be enrolled in the trial in the opinion of the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent chemoradiotherapy group<br>Interventions: Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions. | Drug: Paclitaxel<br>* paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5<br>Drug: Carboplatin<br>* carboplatin AUC=2, ivgtt, d1, qw*5<br>Radiation: Radiotherapy<br>* 1.8Gy/d, d1-5/week, 28Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years |