Spots Global Cancer Trial Database for S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

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Trial Identification

Brief Title: S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Official Title: Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Study ID: NCT02913066

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S-1 concurrent radiotherapy

S-1 plus Cisplatin concurrent radiotherapy

Study Description

Brief Summary: Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Detailed Description: Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy; control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 \~ 42 days, plus cisplatin first 1\~ 4 days and 29 \~ 33 days. Using IMRT radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, or S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle. Primary Outcome Measure is complete remission rate. Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.