A Phase 3 interventional study of cisplatin and paclitaxel in Esophageal Neoplasm, sponsored by Henan Cancer Hospital. Completed at 9 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Henan Cancer Hospital · Phase 3, Interventional, and Treatment
The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.
The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.
The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 413 are open to participants now.
This study's planned enrollment of 528 is above the median of 44 across 1,416 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
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Exclusion Criteria:
Neo-adjuvant chemotherapy(cisplatin and paclitaxel): 1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Drug: cisplatin and paclitaxel
Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Also known as: TP
Overall survival rate
Time frame: 5 years
Overall survival rate
Time frame: 1 years and 3 years
Disease free survival
Time frame: 5 years
assessment in perioperation-Removal rate (R0 resection rate)
The R0 resection rate of two groups
Time frame: perioperative period
assessment in perioperation-Rate of Operative Complication
Complication rate after operation before discharge
Time frame: perioperative period
assessment in perioperation-Mortality of perioperation
Mortality of perioperation 20 days before operation and 30 days after operation
Time frame: perioperative period
assessment in perioperation-Days of Hospitalization
Days of Hospitalization after operation
Time frame: perioperative period
assessment in perioperation-Thoracic Drainage
Thoracic Drainage days
Time frame: perioperative period
assessment in perioperation-Quantity of bleeding
blood lose during operation
Time frame: perioperative period
assessment in perioperation-Time of operation
the time from open thoracic cavity to the closure of the thoracic cavity
Time frame: perioperative period
Quality of life
ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30
Time frame: 1 years
efficacy of neo-adjuvant chemotherapy--response rate
Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.
Time frame: 1-4 days before operation
toxicities of neo-adjuvant chemotherapy
According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol
Time frame: from chemotherapy to perioperative period
prognostic factors
prognostic factors for overall survival of both groups
Time frame: 5 years
predictive factors
predictive factors for the efficiency of neo-adjuvant chemotherapy
Time frame: 2 years
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital