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

Phase 2
Terminated
Conditions
Inoperable Early Stage Non-small Cell Lung Cancer
Interventions
Radiation: hypofractionated radiation therapy
Registration Number
NCT01138748
Lead Sponsor
University Hospital, Ghent
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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
5
Inclusion Criteria
  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • > 18 years old
  • men and women
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Radiation therapyhypofractionated radiation therapy-
Primary Outcome Measures
NameTimeMethod
development and validation of a multi-variate predictive modelfrom 2 to 5 years

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
NameTimeMethod
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

Trial Locations

Locations (1)

University Hospital Ghent

🇧🇪

Ghent, Belgium

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