Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Pa... | NCT01872403

ID	Type	Description	Link
FAHGuangzhou011	Registry Identifier	FAHGuangzhou

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2015Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

May 15, 2013

First Submission Date that Met QC Criteria

Jun 6, 2013

First Posted Date

Jun 7, 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

Jun 6, 2013

Last Update Posted Date

Jun 7, 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

Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.

Detailed Description

Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore, this program is applied to neoadjuvant therapy, may obtain better tumor pathological remission rate, improve the operation resection rate, thus improve the prognosis.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB 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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nanoparticle albumin-bound paclitaxel	Experimental	Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung	Drug: nanoparticle albumin-bound paclitaxel/carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nanoparticle albumin-bound paclitaxel/carboplatin	Drug	Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor ORR 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
PFS		From date of surgery until the date of first documented progression, assessed up to 30 months

Other Outcomes

Measure	Description	Time Frame
The rate of pathology down-stage of lymph nodes		1 day (the date of surgery)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.

2.18 years or older 3.ECOG Performance Status no more than 2; 4.Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI; 5.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5 x 10E9/L, platelets 100 x 10E9/L; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases; 8.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).

Exclusion Criteria:

Any systemic anticancer treatment for NSCLC
Local radiotherapy for NSCLC.
In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
Any instability in systemic disease, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
HIV infection;
Allergic to paclitaxel or Platinum;
mixed with adenocarcinoma, small cell lung cancer;
Pregnant or lactating women;
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

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
jianxing he, MD	Contact	+86-02-83062808		hejx@vip.163.com
xinyun yang, master	Contact	+86-02-83062808		yxy701@126.com

Overall Officials

Name	Affiliation	Role
jianxing he, MD	The First Affiliated Hospital of Guangzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Guangzhou Medical College	Recruiting	Guangzhou	Guangdong	510120	China

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D013660	Taxes
D016190	Carboplatin
C053518	CP protocol

ID	Term
D004467	Economics
D004472	Health Care Economics and Organizations
D056831	Coordination Complexes
D009930	Organic Chemicals