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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel, Cisplatin
* Radiation: neoadjuvant chemoradiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemotherapy group<br>Patients in this group will receive neoadjuvant chemotherapy. | Drug: Paclitaxel, Cisplatin<br>* Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles<br>|
| Experimental: Chemoradiation group<br>Patients in this group will receive neoadjuvant chemoradiation therapy. | Radiation: neoadjuvant chemoradiation therapy<br>* Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d*23<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 year | 
| pathological complete response |  | 3 months | 
| adverse events |  | 3 months | 
| postoperative complications |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma, neoadjuvant chemotherapy, neoadjuvant chemoradiation therapy, randomized controlled, survival