Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nanoparticle albumin-bound paclitaxel 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
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:
Other Names:
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Outcome Measures
Primary Outcome Measures
- Tumor ORR and Number of Adverse Events [From date of randomization until the date of progression, assessed up to 2 months]
Secondary Outcome Measures
- PFS [From date of surgery until the date of first documented progression, assessed up to 30 months]
Other Outcome Measures
- The rate of pathology down-stage of lymph nodes [1 day (the date of surgery)]
Eligibility Criteria
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:
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Any systemic anticancer treatment for NSCLC
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Local radiotherapy for NSCLC.
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In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
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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
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HIV infection;
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Allergic to paclitaxel or Platinum;
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mixed with adenocarcinoma, small cell lung cancer;
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Pregnant or lactating women;
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Other researchers believe that does not fit into the group
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Guangzhou Medical College | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
Investigators
- Principal Investigator: jianxing he, MD, The First Affiliated Hospital of Guangzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FAH20120906
- FAHGuangzhou011