Clinical trial NCT01258192: Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients
Official title: Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
neoadjuvant chemotherapy
albumin-bound paclitaxel
cisplatin
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2010-12-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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).

Primary outcomes:
measure: response to induction therapy
timeFrame: 2 years
Secondary outcomes:
measure: rate of complete pathological response
timeFrame: 2 years
measure: R0 resection rate.
timeFrame: 2 years
measure: 3 years disease free and overall survival
timeFrame: 5 years
measure: safety and tolerability
timeFrame: From time of consent to last visit
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Weimin Mao, MD
role: STUDY_CHAIR
References:
citation: Fan Y, Jiang Y, Zhou X, Chen Q, Huang Z, Xu Y, Gong L, Yu H, Yang H, Liu J, Lei T, Zhao Q, Mao W. Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma. Oncotarget. 2016 Aug 2;7(31):50624-50634. doi: 10.18632/oncotarget.9562.