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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00836160
First received: February 3, 2009
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PFS of the third-line therapy [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836160

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00836160     History of Changes
Other Study ID Numbers: NIS-OTW-DUM-2008/1
Study First Received: February 3, 2009
Last Updated: September 19, 2012
Health Authority: Taiwan: Institutional Review Board
Taiwan: Department of Health

Keywords provided by AstraZeneca:
EGFR-TKI therapy
NSCLC
Efficacy

ClinicalTrials.gov processed this record on May 19, 2013