NCT02976909

Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma

Paclitaxel In Combination With Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Yuhong Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and 5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma.

Detailed description

Esophageal cancer is one of the most common malignant tumors in China. In Asian countries, esophageal squamous carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node metastasis are initially diagnosed as borderline-resectable, which means patients may be able to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0 resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events than docetaxel. Based on the research situation mentioned above, the investigators decided to conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous carcinoma.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel+Cisplatin+5fluorouracil	Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-11-29
• Last updated: 2023-02-17

Locations

1 site across 1 country: China