Non-small Cell Lung Cancer
Conditions
Keywords
Squamous Cell Carcinoma of the lung
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.
Interventions
DRUGnanoparticle 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:
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor ORR and Number of Adverse Events | From date of randomization until the date of progression, assessed up to 2 months |
Secondary
| Measure | Time frame |
|---|---|
| PFS | From date of surgery until the date of first documented progression, assessed up to 30 months |
Other
| Measure | Time frame |
|---|---|
| The rate of pathology down-stage of lymph nodes | 1 day (the date of surgery) |
Countries
China
Contacts
Primary Contactjianxing he, MD
Backup Contactxinyun yang, master
Outcome results
None listed