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

NCT ID: NCT02033538

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

Brief 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.

Detailed 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.

Conditions

Squamous Cell Carcinoma of Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nanoparticle albumin-bound paclitaxel

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Group Type: EXPERIMENTAL

nanoparticle albumin-bound paclitaxel

Intervention Type: DRUG

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Interventions

nanoparticle albumin-bound paclitaxel

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Intervention Type: DRUG

Other Intervention Names

nab-paclitaxel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZYTOP1403

Identifier Type: -

Identifier Source: org_study_id