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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01872403
• Other study ID #: FAH20120906
• Secondary ID: FAHGuangzhou011
• Status: Recruiting
• Phase: Phase 2
• First received: May 15, 2013
• Last updated: June 6, 2013
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: June 2013
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: jianxing he, MD
• Phone: +86-02-83062808
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• nanoparticle albumin-bound paclitaxel/carboplatin
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage ? B and IIIA squamous cell carcinoma of the lung:

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of pathology down-stage of lymph nodes		1 day (the date of surgery)	No
Primary	Tumor ORR and Number of Adverse Events		From date of randomization until the date of progression, assessed up to 2 months	Yes
Secondary	PFS		From date of surgery until the date of first documented progression, assessed up to 30 months	No