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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01258192

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: albumin-bound paclitaxel plus cisplatin	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nab-paclitaxel plus cisplatin	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. Other Names: nab-paclitaxel

Arm

Intervention/Treatment

Experimental: nab-paclitaxel plus cisplatin

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.

Other Names:

nab-paclitaxel

Outcome Measures

Primary Outcome Measures

response to induction therapy [2 years]
The response to induction therapy will be evaluated

Secondary Outcome Measures

rate of complete pathological response [2 years]
The rate of complete pathological response will be evaluated
R0 resection rate. [2 years]
Complete resection rate to pre-operative chemotherapy will be assessed
3 years disease free and overall survival [5 years]
Three years disease free and overall survival will be evaluated.
safety and tolerability [From time of consent to last visit]
To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ 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).