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

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhu Yujia
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

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