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

Squamous Cell Carcinoma of Esophagus Clinical Trial

Official title:

A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02033538
• Other study ID #: ZYTOP1403
• Status: Withdrawn
• Phase: Phase 2
• First received: December 16, 2013
• Last updated: March 4, 2015
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Squamous Cell Carcinoma of Esophagus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	The first affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	pathological response rate and clinical response rate	From date of treatment until the date of progression, assessed up to 2 months	No
Secondary	Overall survival		Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months	No
Secondary	Progression-free survival		Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months	No
Secondary	Adverse events	Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0	During the chemotherapy,an expected average of 3 weeks	Yes