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A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

NCT01497041 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-12-22

No results posted yet for this study

Summary

1. Goals

The primary goal of this phase II trial is to:

evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment

Secondary goals are to:

evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous
  • Carcinoma, Large Cell

Interventions

DRUG

Docetaxel

Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks

DRUG

Oxaliplatin

Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks

Sponsors & Collaborators

  • Korean South West Oncology Group

    lead NETWORK

Principal Investigators

  • Sang Byung Bae, M.D. · Soonchunhyang University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497041 on ClinicalTrials.gov