Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: nanoparticle albumin-bound paclitaxel

• Registration Number: NCT02016209
• Lead Sponsor: Zhejiang University

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 .

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-14
• Last Update Submitted: 2013-12-14
• Study First Posted: 2013-12-19
• Last Update Posted: 2013-12-19
• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nanoparticle albumin-bound paclitaxel	nanoparticle albumin-bound paclitaxel	Neoadjuvant chemotherapy of platinum-based nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer

Primary Outcome Measures

Name	Time	Method
Tumor response rate and Number of Adverse Events	From date of randomization until the date of progression, assessed up to 2 months

Secondary Outcome Measures

Name	Time	Method
disease free survival	From date of surgery until the date of first documented progression, assessed up to 36 months

Trial Locations

Locations (1)

The first affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China