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Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836160
First Posted: February 4, 2009
Last Update Posted: September 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose

This is an observational prospective study that investigates only daily practice. The prescription of anti-cancer medicine is separated from the decision to include the patient in this study. In addition, the assignment of the patient to a particular therapy or therapeutic strategy is not decided in advance by this study protocol, but falls within current practice.

The patient who fulfils eligible criteria will be enrolled when starts to receive the second-line EGFR-TKI therapy. The frequency of tumor response evaluation by RECIST criteria follows the investigator's discretion as daily practice.


Condition
Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PFS of the third-line therapy [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • Overall objective tumor response (complete response [CR] + partial response [PR]) of the third-line therapy by RECIST criteria [ Time Frame: 9 months ]

Enrollment: 36
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The EGFR-TKI receiver who are suitable for third-line therapy will be followed up for the regimen of the third-line anti-microtubule agents or non-anti-microtubule agents
Criteria

Inclusion Criteria:

  • At least one measurable lesion according to RECIST criteria
  • Histologically or cytologically confirmed NSCLC of adeno histology
  • Locally progressed or metastasized on or after first-line chemotherapy. The imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acce

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836160


Locations
Taiwan
Research Site
Gueishan Township, Taiwan
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00836160     History of Changes
Other Study ID Numbers: NIS-OTW-DUM-2008/1
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by AstraZeneca:
EGFR-TKI therapy
NSCLC
Efficacy