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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
albumin-bound paclitaxel plus cisplatin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, neoadjuvant chemotherapy, albumin-bound paclitaxel, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel plus cisplatin

Arm Description

Outcomes

Primary Outcome Measures

response to induction therapy
The response to induction therapy will be evaluated

Secondary Outcome Measures

rate of complete pathological response
The rate of complete pathological response will be evaluated
R0 resection rate.
Complete resection rate to pre-operative chemotherapy will be assessed
3 years disease free and overall survival
Three years disease free and overall survival will be evaluated.
safety and tolerability
To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects

Full Information

First Posted
December 3, 2010
Last Updated
July 28, 2014
Sponsor
Zhejiang Cancer Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01258192
Brief Title
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients
Acronym
nabPCESCC
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, neoadjuvant chemotherapy, albumin-bound paclitaxel, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nab-paclitaxel plus cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
albumin-bound paclitaxel plus cisplatin
Other Intervention Name(s)
nab-paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
response to induction therapy
Description
The response to induction therapy will be evaluated
Time Frame
2 years
Secondary Outcome Measure Information:
Title
rate of complete pathological response
Description
The rate of complete pathological response will be evaluated
Time Frame
2 years
Title
R0 resection rate.
Description
Complete resection rate to pre-operative chemotherapy will be assessed
Time Frame
2 years
Title
3 years disease free and overall survival
Description
Three years disease free and overall survival will be evaluated.
Time Frame
5 years
Title
safety and tolerability
Description
To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects
Time Frame
From time of consent to last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27244882
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.
Results Reference
derived

Learn more about this trial

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

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