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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

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ClinicalTrials.gov Identifier: NCT01872403
Recruitment Status : Unknown
Verified June 2013 by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Jianxing He, 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: nanoparticle albumin-bound paclitaxel/carboplatin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: paclitaxel /carboplatin




Primary Outcome Measures :
  1. Tumor ORR and Number of Adverse Events [ Time Frame: From date of randomization until the date of progression, assessed up to 2 months ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: From date of surgery until the date of first documented progression, assessed up to 30 months ]

Other Outcome Measures:
  1. The rate of pathology down-stage of lymph nodes [ Time Frame: 1 day (the date of surgery) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872403


Contacts
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Contact: jianxing he, MD +86-02-83062808 hejx@vip.163.com
Contact: xinyun yang, master +86-02-83062808 yxy701@126.com

Locations
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China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: jianxing HE, MD    +86-20-83062808    hejx@vip.163.com   
Contact: xinyun yang, master    +86-20-83062808    yxy701@126.com   
Principal Investigator: jianxing he, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: jianxing he, MD The First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01872403     History of Changes
Other Study ID Numbers: FAH20120906
FAHGuangzhou011 ( Registry Identifier: FAHGuangzhou )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University:
Squamous Cell Carcinoma of the lung

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action