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Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

NCT ID: NCT02016209

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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 .

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nanoparticle albumin-bound paclitaxel

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

Group Type EXPERIMENTAL

nanoparticle albumin-bound paclitaxel

Intervention Type DRUG

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

Interventions

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nanoparticle albumin-bound paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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nab-paclitaxel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiong Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

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The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Qiong Zhao, PhD

Role: CONTACT

Phone: 0571-87236802

Email: [email protected]

Facility Contacts

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Qiong Zhao, PhD

Role: primary

Other Identifiers

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ZYTOP1402

Identifier Type: -

Identifier Source: org_study_id