Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?

April 12, 2016 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

Can Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis of the Thoracic and Lumbar Spine?- A Retrospective Comparison With Platinum-based Chemotherapy

Not significantly increased survival in T/T

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NSCLC with spinal metastasis

Description

Inclusion Criteria:

  • NSCLC with spinal metastasis

Exclusion Criteria:

  • brain metastasis and expected survival < 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
targeted therapy
according to national healthy policy, targeted therapy is the optional therapy
Drug: Gefitinib
Other Names:
  • Targeted therapy
traditional chemotherapy
according to national healthy policy, chemotherapy is the first line treatment.
Drug: Gefitinib
Other Names:
  • Targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status.
Time Frame: postoperation to mortality, up to 2 year
postoperation to mortality, up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (ESTIMATE)

April 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-02-006CC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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