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

Zhejiang University

Status and phase

Withdrawn

Phase 2

Conditions

Squamous Cell Carcinoma of Esophagus

Treatments

Drug: nanoparticle albumin-bound paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT02033538

ZYTOP1403

Details and patient eligibility

About

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.

Full description

In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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