Chemotherapy in Treating Patients With Lung Cancer (FRAME)
August 23, 2012 updated by: Eli Lilly and Company
First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival
This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions.
Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions.
All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1610
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients (> 18 yrs.)
initiating first-line treatment for advanced or metastatic (stage IIIB-IV) NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents treated in public hospitals, private hospitals or by office based physicians
Description
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV
- Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents
- 18 years of age or older
Exclusion Criteria:
- Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study
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 |
|---|---|
|
pemetrexed + platinum
Patients with pemetrexed + platinum doublet, with or without additional targeted agents
|
Dosage, dosage form, frequency and duration according to daily hospital practice
|
|
gemcitabine + platinum
Patients with gemcitabine + platinum doublet, with or without additional targeted agents
|
Dosage, dosage form, frequency and duration according to daily hospital practice
|
|
taxanes + platinum
Patients with taxanes + platinum doublet, with or without additional targeted agents
|
Dosage, dosage form, frequency and duration according to daily hospital practice
|
|
vinorelbine + platinum
Patients with vinorelbine + platinum doublet, with or without additional targeted agents
|
Dosage, dosage form, frequency and duration according to daily hospital practice
|
|
others + platinum
Patients with other platinum-based doublet, with or without additional targeted agents
|
Dosage, dosage form, frequency and duration according to daily hospital practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
|
Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
One-year survival rate
Time Frame: 12 months
|
12 months
|
|
Progression-free survival
Time Frame: Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
|
Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
|
|
Best tumor response
Time Frame: Treatment start to progression or treatment end
|
Treatment start to progression or treatment end
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 1, 2010
First Submitted That Met QC Criteria
February 10, 2010
First Posted (Estimate)
February 12, 2010
Study Record Updates
Last Update Posted (Estimate)
August 24, 2012
Last Update Submitted That Met QC Criteria
August 23, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13095
- H3E-EW-B012 (Other Identifier: Eli Lilly and Company)
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.