Back to resultsPrediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers (PEARL-2)
Primary Purpose
Inoperable Early Stage Non-small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
hypofractionated radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Inoperable Early Stage Non-small Cell Lung Cancer focused on measuring inoperable early stage non-small cell lung cancer, radiation therapy
Eligibility Criteria
Inclusion Criteria:
- Proof of cT1a/b - 2a/b N0M0 NSCLC
- Informed Consent signed
- Resectable tumour
- > 18 years old
- men and women
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation therapy
Arm Description
Outcomes
Primary Outcome Measures
development and validation of a multi-variate predictive model
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
Secondary Outcome Measures
the clinical response and complication rate
local, regional or distant failure
progression free survival
disease specific overall survival
Full Information
NCT ID
NCT01138748
First Posted
June 4, 2010
Last Updated
February 1, 2013
Sponsor
University Hospital, Ghent
Collaborators
Nationaal Kankerplan
1. Study Identification
Unique Protocol Identification Number
NCT01138748
Brief Title
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
Acronym
PEARL-2
Official Title
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Nationaal Kankerplan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.
The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inoperable Early Stage Non-small Cell Lung Cancer
Keywords
inoperable early stage non-small cell lung cancer, radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation therapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Intervention Description
hypofractionated radiation therapy
Primary Outcome Measure Information:
Title
development and validation of a multi-variate predictive model
Description
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
Time Frame
from 2 to 5 years
Secondary Outcome Measure Information:
Title
the clinical response and complication rate
Time Frame
from 2 to 5 years
Title
local, regional or distant failure
Time Frame
from 2 to 5 years
Title
progression free survival
Time Frame
from 2 to 5 years
Title
disease specific overall survival
Time Frame
from 2 to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proof of cT1a/b - 2a/b N0M0 NSCLC
Informed Consent signed
Resectable tumour
> 18 years old
men and women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Van Meerbeeck, MD,PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of University Hospital Ghent
Learn more about this trial
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
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