Inoperable Early Stage Non-small Cell Lung Cancer Clinical Trial
— PEARL-2Official title:
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
Verified date | February 2013 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 5 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Proof of cT1a/b - 2a/b N0M0 NSCLC - Informed Consent signed - Resectable tumour - > 18 years old - men and women |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Nationaal Kankerplan |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | from 2 to 5 years | No |
Secondary | the clinical response and complication rate | from 2 to 5 years | No | |
Secondary | local, regional or distant failure | from 2 to 5 years | No | |
Secondary | progression free survival | from 2 to 5 years | No | |
Secondary | disease specific overall survival | from 2 to 5 years | No |