Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal squamous cell carcinoma, neoadjuvant chemotherapy, neoadjuvant chemoradiation therapy, randomized controlled, survival
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.
Interventions
Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles
RADIATIONneoadjuvant chemoradiation therapy
Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival | 5 year |
| pathological complete response | 3 months |
| adverse events | 3 months |
| postoperative complications | 3 months |
Countries
China
Contacts
Primary ContactHaibo Sun
Outcome results
None listed