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Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01138748
Acronym
PEARL-2
Enrollment
5
Registered
2010-06-07
Start date
2010-11-30
Completion date
2012-10-31
Last updated
2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable Early Stage Non-small Cell Lung Cancer

Keywords

inoperable early stage non-small cell lung cancer, radiation therapy

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

Interventions

RADIATIONhypofractionated radiation therapy

hypofractionated radiation therapy

Sponsors

Nationaal Kankerplan
CollaboratorUNKNOWN
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Proof of cT1a/b - 2a/b N0M0 NSCLC * Informed Consent signed * Resectable tumour * \> 18 years old * men and women

Design outcomes

Primary

MeasureTime frameDescription
development and validation of a multi-variate predictive modelfrom 2 to 5 yearsTo develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.

Secondary

MeasureTime frame
the clinical response and complication ratefrom 2 to 5 years
local, regional or distant failurefrom 2 to 5 years
progression free survivalfrom 2 to 5 years
disease specific overall survivalfrom 2 to 5 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026