Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.

Official Title
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A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Docetaxel plus cisplatin
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biopsy-confirmed esophageal squamous cell carcinoma age ≤ 70 years old, Karnofsky performance status ≥ 70, R0 esophagectomy according to the pathological examination of the resected specimens, postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin <1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1>0.8 L;. no previous treatment or severe complications Written informed consent Exclusion Criteria: previous treatment with chemotherapy or radiotherapy greater than 3 months after surgery complete esophageal obstruction after surgery, esophageal perforation; 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； patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease； drug addiction, Alcoholism or AIDS; uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; with clear chemotherapy drug allergy participation in other interventional clinical trials within 30 days;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: concurrent chemoradiotherapy group<br>All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin). | Drug: Docetaxel plus cisplatin<br>* cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks<br>Radiation: radiotherapy<br>* radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)<br>|
| Active Comparator: radiotherapy group<br>All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week). | Radiation: radiotherapy<br>* radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。 | From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | From the date of randomization until the date of death | From date of randomization to death from any cause, assessed up to 3 years | 
| treatment-related toxicities | Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0 | From the date of randomization until six months after treatment completion | 
| Quality of life(QOL) | Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant therapy, chemotherapy, radiotherapy, esophageal neoplasma