Status:
COMPLETED
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
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 resect...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01258192
Start Date
January 1 2011
End Date
October 1 2012
Last Update
July 29 2014
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022