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

NCT ID: NCT01872403

Last Updated: 2013-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nanoparticle albumin-bound paclitaxel

Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung

Group Type EXPERIMENTAL

nanoparticle albumin-bound paclitaxel/carboplatin

Intervention Type DRUG

Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:

Interventions

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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:

Intervention Type DRUG

Other Intervention Names

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paclitaxel /carboplatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

The First Affiliated Hospital of Guangzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jianxing he, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jianxing he, MD

Role: CONTACT

+86-02-83062808

xinyun yang, master

Role: CONTACT

+86-02-83062808

Facility Contacts

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jianxing HE, MD

Role: primary

+86-20-83062808

xinyun yang, master

Role: backup

+86-20-83062808

Other Identifiers

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FAHGuangzhou011

Identifier Type: REGISTRY

Identifier Source: secondary_id

FAH20120906

Identifier Type: -

Identifier Source: org_study_id

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