Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Pa... | NCT02016209

Studies
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

NCT02016209

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

Dec 19, 2013Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Non Small Cell Lung Cancer

Interventions

nanoparticle albumin-bound paclitaxel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Dec 7, 2013

First Submission Date that Met QC Criteria

Dec 14, 2013

First Posted Date

Dec 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
nanoparticle albumin-bound paclitaxel	Drug	Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer	nanoparticle albumin-bound paclitaxel

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiong Zhao, PhD	Contact	0571-87236802		doczq.2008@gmail.com

Overall Officials

Name	Affiliation	Role
Qiong Zhao, PhD	First Affiliated Hospital of Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital, Zhejiang University		Hangzhou	Zhejiang	310003	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013660	Taxes
C520255	130-nm albumin-bound paclitaxel

Ancestor Terms

ID	Term
D004467	Economics
D004472	Health Care Economics and Organizations

Browse Leaves

Not provided

Browse Branches

Not provided