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Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel/carboplatin
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Squamous Cell Carcinoma of the lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
  5. HIV infection;
  6. Allergic to paclitaxel or Platinum;
  7. mixed with adenocarcinoma, small cell lung cancer;
  8. Pregnant or lactating women;
  9. Other researchers believe that does not fit into the group

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nanoparticle albumin-bound paclitaxel

Arm Description

Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung

Outcomes

Primary Outcome Measures

Tumor ORR and Number of Adverse Events

Secondary Outcome Measures

PFS

Full Information

First Posted
May 15, 2013
Last Updated
June 6, 2013
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01872403
Brief Title
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung
Official Title
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung: Parallel Control and Single Center
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Squamous Cell Carcinoma of the lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nanoparticle albumin-bound paclitaxel
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung
Intervention Type
Drug
Intervention Name(s)
nanoparticle albumin-bound paclitaxel/carboplatin
Other Intervention Name(s)
paclitaxel /carboplatin
Intervention Description
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:
Primary Outcome Measure Information:
Title
Tumor ORR and Number of Adverse Events
Time Frame
From date of randomization until the date of progression, assessed up to 2 months
Secondary Outcome Measure Information:
Title
PFS
Time Frame
From date of surgery until the date of first documented progression, assessed up to 30 months
Other Pre-specified Outcome Measures:
Title
The rate of pathology down-stage of lymph nodes
Time Frame
1 day (the date of surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianxing he, MD
Phone
+86-02-83062808
Email
hejx@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xinyun yang, master
Phone
+86-02-83062808
Email
yxy701@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianxing he, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianxing HE, MD
Phone
+86-20-83062808
Email
hejx@vip.163.com
First Name & Middle Initial & Last Name & Degree
xinyun yang, master
Phone
+86-20-83062808
Email
yxy701@126.com
First Name & Middle Initial & Last Name & Degree
jianxing he, MD

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung

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