NCT01872403

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

2.7 years

First QC Date

May 15, 2013

Last Update Submit

June 6, 2013

Conditions

Non-small Cell Lung Cancer

Keywords

Squamous Cell Carcinoma of the lung

Outcome Measures

Primary Outcomes (1)

  • Tumor ORR and Number of Adverse Events

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

Secondary Outcomes (1)

  • PFS

    From date of surgery until the date of first documented progression, assessed up to 30 months

Other Outcomes (1)

  • The rate of pathology down-stage of lymph nodes

    1 day (the date of surgery)

Study Arms (1)

nanoparticle albumin-bound paclitaxel

EXPERIMENTAL

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

Interventions

nanoparticle albumin-bound paclitaxel/carboplatinDRUG

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

Also known as: paclitaxel /carboplatin
nanoparticle albumin-bound paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.
  • 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).

You may not qualify if:

  • Any systemic anticancer treatment for NSCLC
  • Local radiotherapy for NSCLC.
  • In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
  • 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
  • HIV infection;
  • Allergic to paclitaxel or Platinum;
  • mixed with adenocarcinoma, small cell lung cancer;
  • Pregnant or lactating women;
  • Other researchers believe that does not fit into the group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TaxesCarboplatinCP protocol

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsCoordination ComplexesOrganic Chemicals

Study Officials

  • jianxing he, MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jianxing he, MD

CONTACT

+86-02-83062808hejx@vip.163.com

xinyun yang, master

CONTACT

+86-02-83062808yxy701@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

First Submitted

May 15, 2013

First Posted

June 7, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2015

Study Completion

December 1, 2017

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

CN(1)