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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor ORR and Number of Adverse Events

Outcome Time Frame:

From date of randomization until the date of progression, assessed up to 2 months

Safety Issue:

Yes

Principal Investigator

jianxing he, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Guangzhou Medical University

Authority:

United States: Food and Drug Administration

Study ID:

FAH20120906

NCT ID:

NCT01872403

Start Date:

October 2012

Completion Date:

December 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma of the lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms

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