Status:
UNKNOWN
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 neoadj...
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01872403
Start Date
October 1 2012
End Date
December 1 2017
Last Update
June 7 2013
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120