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

This study is currently recruiting participants.
Verified June 2012 by Zhejiang Cancer Hospital
Sponsor:
Collaborator:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01258192
First received: December 3, 2010
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Esophageal Squamous Cell Carcinoma
Drug: albumin-bound paclitaxel plus cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • response to induction therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The response to induction therapy will be evaluated


Secondary Outcome Measures:
  • rate of complete pathological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The rate of complete pathological response will be evaluated

  • R0 resection rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Complete resection rate to pre-operative chemotherapy will be assessed

  • 3 years disease free and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Three years disease free and overall survival will be evaluated.

  • safety and tolerability [ Time Frame: From time of consent to last visit ] [ Designated as safety issue: Yes ]
    To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects


Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: nab-paclitaxel

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258192

Contacts
Contact: Weimin Mao, MD 0086-571-88122032 maowm1218@163.com
Contact: Zhongyu Ma, MD 0086-13777556534 mazhy1@qq.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Weimin Mao, MD    0086-571-88122032    maowm1218@163.com   
Contact: Zhongyu Ma, MD    0086-13777556534    mazhy1@qq.com   
Principal Investigator: Weimin Mao, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Study Chair: Weimin Mao, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01258192     History of Changes
Other Study ID Numbers: ZhejiangCH-ESCC-01
Study First Received: December 3, 2010
Last Updated: June 26, 2012
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang Cancer Hospital:
esophageal squamous cell carcinoma
neoadjuvant chemotherapy
albumin-bound paclitaxel
cisplatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 20, 2014