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

Henan Cancer Hospital

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Radiation: neoadjuvant chemoradiation therapy; Drug: Paclitaxel, Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04138212

2019082223

Details and patient eligibility

About

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.

Enrollment: 456 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Chemotherapy group

Active Comparator group

Description:

Patients in this group will receive neoadjuvant chemotherapy.

Treatment:

Drug: Paclitaxel, Cisplatin

Chemoradiation group

Experimental group

Description:

Patients in this group will receive neoadjuvant chemoradiation therapy.

Treatment:

Radiation: neoadjuvant chemoradiation therapy