NCT04138212

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

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 squamous 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 squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous 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, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel, Cisplatin	Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles
RADIATION	neoadjuvant chemoradiation therapy	Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23

Timeline

• Start date: 2019-10-22
• Primary completion: 2023-12-21
• Completion: 2028-12-21
• First posted: 2019-10-24
• Last updated: 2022-08-09

Locations

1 site across 1 country: China