NCT00836160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

February 3, 2009

Last Update Submit

September 19, 2012

Conditions

Cancer

Keywords

EGFR-TKI therapyNSCLCEfficacy

Outcome Measures

Primary Outcomes (1)

  • PFS of the third-line therapy

    9 months

Secondary Outcomes (1)

  • Overall objective tumor response (complete response [CR] + partial response [PR]) of the third-line therapy by RECIST criteria

    9 months

Study Arms (2)

1

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gueishan Township, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

TW(1)