Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung

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.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 Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: nanoparticle albumin-bound paclitaxel/carboplatin

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: xinyun yang, master; Phone Number: +86-02-83062808; Email: yxy701@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College
      • Contact: xinyun yang, master; Phone Number: +86-20-83062808; Email: yxy701@126.com
      • Principal Investigator: jianxing he, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: paclitaxel /carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
PFS	From date of surgery until the date of first documented progression, assessed up to 30 months

Other Outcome Measures

Outcome Measure	Time Frame
The rate of pathology down-stage of lymph nodes	1 day (the date of surgery)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (ESTIMATE): June 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Squamous Cell Carcinoma of the lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms, Squamous Cell; Lung Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: FAH20120906; FAHGuangzhou011 (REGISTRY: FAHGuangzhou)