Back to resultsNeoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
1.Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA .
2.18 years or older 3.Performance Status 0 to 2; 4.Appraisable disease; 5.patients can tolerant chemotherapy; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).
Exclusion Criteria:
1.Any systemic anticancer treatment for NSCLC；2.Local radiotherapy for NSCLC；3.In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.4.Any instability in systemic disease; 5.Allergic to paclitaxel or Platinum;6.Pregnant or lactating women;7.Other researchers believe that does not fit into the group
Sites / Locations
- The first affiliated hospital, Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanoparticle albumin-bound paclitaxel
Arm Description
Neoadjuvant chemotherapy of platinum-based nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
Outcomes
Primary Outcome Measures
Tumor response rate and Number of Adverse Events
Secondary Outcome Measures
disease free survival
Full Information
NCT ID
NCT02016209
First Posted
December 7, 2013
Last Updated
December 14, 2013
Sponsor
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT02016209
Brief Title
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer
Official Title
Phase II Study of Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin/Cisplatin in Stage Ⅱ B and IIIA Non-small Cell Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in neoadjuvant therapy.
Detailed Description
The main purpose of this study is to observe the safety and efficacy of platinum-based albumin-bound paclitaxel regimen in the treatment of non-small cell lung cancer (NSCLC) of stage Ⅱ B and IIIA .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nanoparticle albumin-bound paclitaxel
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy of platinum-based nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
Intervention Type
Drug
Intervention Name(s)
nanoparticle albumin-bound paclitaxel
Other Intervention Name(s)
nab-paclitaxel
Intervention Description
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
Primary Outcome Measure Information:
Title
Tumor response rate and Number of Adverse Events
Time Frame
From date of randomization until the date of progression, assessed up to 2 months
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
From date of surgery until the date of first documented progression, assessed up to 36 months
Other Pre-specified Outcome Measures:
Title
dynamic circulating tumor cell changes during treatment
Time Frame
baseline, 3 weeks and up to progression disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA .
2.18 years or older 3.Performance Status 0 to 2; 4.Appraisable disease; 5.patients can tolerant chemotherapy; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).
Exclusion Criteria:
1.Any systemic anticancer treatment for NSCLC；2.Local radiotherapy for NSCLC；3.In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.4.Any instability in systemic disease; 5.Allergic to paclitaxel or Platinum;6.Pregnant or lactating women;7.Other researchers believe that does not fit into the group
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiong Zhao, PhD
Phone
0571-87236802
Email
doczq.2008@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiong Zhao, PhD
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiong Zhao, PhD
Phone
0571-87236802
Email
doczq.2008@gmail.com
First Name & Middle Initial & Last Name & Degree
Qiong Zhao, PhD
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer
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