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

NCT ID: NCT01258192

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel plus cisplatin

Group Type: EXPERIMENTAL

albumin-bound paclitaxel plus cisplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

nab-paclitaxel

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weimin Mao, MD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 27244882 (View on PubMed)

Other Identifiers

ZhejiangCH-ESCC-01

Identifier Type: -

Identifier Source: org_study_id