Overview

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Withdrawn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