Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients

Esophageal Squamous Cell Carcinoma Clinical Trial

— nabPCESCC  

Official title:

Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258192
• Other study ID #: ZhejiangCH-ESCC-01
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: July 28, 2014
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2014
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

Description:

A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases.A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone.The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage ?-? by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.

• Age ranges from 18 to 70 years.

• Patients must not have received any prior anticancer therapy.

• Performance status of 0 to 1

• Estimated life expectancy of at least 6 months.

• Tumor can be measured according to RECIST criteria

• Signed informed consent document on file.

• Females with childbearing potential must have a negative serum pregnancy

• Adequate organ function including the following:

Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate=60ml/min. test within 7 days prior to study enrollment.

Exclusion Criteria:

• Carcinoma at the upper part of esophagus

• Histologic diagnosis of adenocarcinoma of esophagus.

• Prior treatment for esophageal cancer.

• Active infection.

• Pregnant or breast feeding.

• History of significant neurological or mental disorder, including seizures or dementia.

• Prior invasive malignancy in 5 years (except for carcinoma in situ).

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
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• albumin-bound paclitaxel plus cisplatin
neo-chemotherapy program:Albumin-bound paclitaxel:100 mg/m2, IV (in the vein) on days 1,8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle.Number of Cycles: 2 cycles before operation.If it is effective ,2 cycles will be given in 6 weeks after radical resection.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to induction therapy	The response to induction therapy will be evaluated	2 years	No
Secondary	rate of complete pathological response	The rate of complete pathological response will be evaluated	2 years	No
Secondary	R0 resection rate.	Complete resection rate to pre-operative chemotherapy will be assessed	2 years	No
Secondary	3 years disease free and overall survival	Three years disease free and overall survival will be evaluated.	5 years	No
Secondary	safety and tolerability	To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects	From time of consent to last visit	Yes