Trial intelligence / Profile preview

Sodium Glycididazole with Preoperative Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

NCT02721550Phase 4

Key facts

Status
Terminated
Start
Aug 2016
Primary completion
Jun 2018
Countries
1
Sponsor
Shandong Cancer Hospital
Modality
Small Molecules
Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
01

Overview

Phase 4, open-label, single-arm trial of sodium glycididazole in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Shandong Cancer Hospital. Primary endpoint: pathologic Complete Response at 1 month. Started Aug 2016; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Sodium Glycididazole + Chemoradiotherapy

    Sodium Glycididazole combined with preoperative concurrent chemoradiotherapy (Paclitaxel/Cisplatin, Docetaxel/Cisplatin, Nedaplatin, or 5-FU based regimens) followed by surgery.

03

Who it enrols

Patients with resectable thoracic ESCC (T2-3, N0-1, M0), ECOG 0-1, and adequate organ function. Excludes prior anti-cancer treatment, distant metastasis, and other malignancies.

04

Endpoints

Primary

  • pathologic Complete Response

Secondary

  • Overall Survival

  • Disease-Free Survival

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