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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: nanoparticle albumin-bound paclitaxel/carboplatin

• Registration Number: NCT01872403
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-05-15
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-06
• Last Update Submitted: 2013-06-06
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2015-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Tumor ORR and Number of Adverse Events	From date of randomization until the date of progression, assessed up to 2 months

Secondary Outcome Measures

Name	Time	Method
PFS	From date of surgery until the date of first documented progression, assessed up to 30 months

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China