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Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiation Therapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

2019-10-29 14:36:42 | BioPortfolio

Summary

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squmous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squmous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal quamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, patholical complete response, postoperative complications, quality of life. The biomarkeres predicting the sensitivity of neoadjuvant therapy will be explored.

Study Design

Conditions

Esophageal Squamous Cell Carcinoma

Intervention

Paclitaxel, Cisplatin, neoadjuvant chemoradiation therapy

Location

Henan Cancer Hospital
Zhengzhou
Henan
China
450008

Status

Recruiting

Source

Henan Cancer Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-29T14:36:42-0400

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