Overview

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

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborator:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
Criteria
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).