Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma

Phase 2

Brief Summary: In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Detailed Description: Esophageal cancer is one of the most fatal malignancies worldwide. Radical surgery has been the primary treatment for patients with resectable esophageal cancer. For medically unfit patients or medically fit patients who decline surgery, definitive radiotherapy plus concurrent chemotherapy has been established as a standard treatment. Since the 1980' s, the most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal cancer was cisplatin (CDDP) plus 5-fluorouracil (5-FU) (the PF regimen). However, locoregionally persistent or recurrent diseases were still quite common and survival remained poor. Several previous studies conducted by the radiation therapy oncology group (RTOG) explored the efficacy of radiation dose escalation, but all results turned out disappointing. And studies incorporating intensified PF regimen or new-generation cytotoxic agents such as paclitaxel and oxaliplatin did not show any advantage over the standard-dosage PF regimen either. In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Recruitment & Eligibility

Inclusion Criteria

patients with histologically proven squamous cell carcinoma of the esophagus
stage II-IVA disease, including metastatic celiac or cervical nodes, according to the sixth edition of American Joint Committee on Cancer (AJCC) staging system for esophageal cancer
aged between 18 and 70 years
Karnofsky Performance Status (KPS) score ≥ 70
adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥ 100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and serum aspartate aminotransferase (AST) level < twice the upper limit of normal, and serum bilirubin level of <1.5 mg/dL), and adequate renal function (creatinine clearance ≥ 50 mL/min)
no other serious medical conditions
life expectancy ≥ 3 months
written informed consent

Exclusion Criteria

detection of distant metastasis (excluding metastatic celiac or cervical nodes) before treatment before treatment
known allergy to CDDP, 5-FU, or docetaxel
pregnancy or breast feeding

Arm && Interventions

Group	Intervention	Description
PF group	Fluorouracil	This is the active comparator group. All patients in this group will receive concurrent chemoradiotherapy with PF regimen (5-fluorouracil plus cisplatin).
DP group	Docetaxel	This is the experimental group. All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	From the date of randomization until the date of death, up to 5 years.

Secondary Outcome Measures

Name	Time	Method
Treatment response rate	From the date of randomization until six weeks after treatment completion.
Progress Free Survival (PFS)	From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Acute treatment-related toxicities	From the date of randomization until six months after treatment completion.

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