Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

NCT02016209 | Unknown Phase 2

• 1 other identifier: ZYTOP1402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response rate and Number of Adverse Events

  From date of randomization until the date of progression, assessed up to 2 months

Secondary Outcomes (1)

• disease free survival

  From date of surgery until the date of first documented progression, assessed up to 36 months

Other Outcomes (1)

• dynamic circulating tumor cell changes during treatment

  baseline, 3 weeks and up to progression disease

Study Arms (1)

nanoparticle albumin-bound paclitaxel

EXPERIMENTAL

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

Interventions

nanoparticle albumin-bound paclitaxel DRUG

Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer

Also known as: nab-paclitaxel

nanoparticle albumin-bound paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA .
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Taxes; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Qiong Zhao, PhD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiong Zhao, PhD

CONTACT

0571-87236802; doczq.2008@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Thoracic Oncology

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

CN (1)