Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)

• Locally advanced disease that is technically operable with curative intent (R0)

• T3, N0 OR T1-3, N+ OR T4, Nx

• No T1-2, N0

• No inoperable T4 (unequivocal organ involvement)

• No distant metastasis, including M1a lymph node status

• Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology

• No carcinoma of the cervical esophagus

• Obstructive tumors allowed

Exclusion Criteria:

• Not suitable to surgery

• cervical Esophageal Carcinoma(distance of incisor tooth<19cm)

• early Esophageal Carcinoma(Stage I)

• complete esophageal obstruction，Esophageal perforation or hematemesis

• other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ

• pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior

• History of serious allergic or castor oil allergy

• Patients who are not suitable to participate in the trial according to researchers