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

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: neoadjuvant chemoradiation therapy; Drug: Paclitaxel, Cisplatin

• Registration Number: NCT04138212
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-20
• Study Start: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-12-21
• Study Completion: 2028-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

• cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
• No metastatic cervical lymph node
• No anti-cancer treatment
• No contraindication for esophagectomy
• No contraindication for chemotherapy or chemoradiation therapy
• PS score 0-1
• Written consent is obtained

Exclusion Criteria

• Previous cancer treatment history
• Concurrent cancer disease in other site
• Tumor length ≥8cm
• Tumor width ≥5cm
• Need continuous steroid treatment
• Cardiac infarction in 6 months
• Psychotic patient
• Can not achieve R0 resection
• Gastric tube can not be used for reconstruction after esophagectomy
• Pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiation group	neoadjuvant chemoradiation therapy	Patients in this group will receive neoadjuvant chemoradiation therapy.
Chemotherapy group	Paclitaxel, Cisplatin	Patients in this group will receive neoadjuvant chemotherapy.

Primary Outcome Measures

Name	Time	Method
overall survival	5 year

Secondary Outcome Measures

Name	Time	Method
adverse events	3 months
pathological complete response	3 months
disease-free survival	5 year
postoperative complications	3 months

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China