Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

December 14, 2013 updated by: Qiong Zhao, Zhejiang University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nanoparticle albumin-bound paclitaxel
Neoadjuvant chemotherapy of platinum-based nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
Drug: nanoparticle albumin-bound paclitaxel
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
Other Names:
  • nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response rate and Number of Adverse Events
Time Frame: From date of randomization until the date of progression, assessed up to 2 months
From date of randomization until the date of progression, assessed up to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: From date of surgery until the date of first documented progression, assessed up to 36 months
From date of surgery until the date of first documented progression, assessed up to 36 months

Other Outcome Measures

Outcome Measure
Time Frame
dynamic circulating tumor cell changes during treatment
Time Frame: baseline, 3 weeks and up to progression disease
baseline, 3 weeks and up to progression disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Qiong Zhao, PhD, The First Affiliated Hospital, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 14, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 14, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYTOP1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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