Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02016209
• Other study ID #: ZYTOP1402
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 7, 2013
• Last updated: December 14, 2013
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2013
• Source: Zhejiang University
• Contact: Qiong Zhao, PhD
• Phone: 0571-87236802
• Email: doczq.2008[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1.Histological or cytological diagnosis of NSCLC of Stage ? 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• nanoparticle albumin-bound paclitaxel
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage ? B and IIIA non-small cell lung cancer

Locations

Country	Name	City	State
China	The first affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dynamic circulating tumor cell changes during treatment		baseline, 3 weeks and up to progression disease	No
Primary	Tumor response rate and Number of Adverse Events		From date of randomization until the date of progression, assessed up to 2 months	Yes
Secondary	disease free survival		From date of surgery until the date of first documented progression, assessed up to 36 months	No