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Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial

Phase 2
Terminated
Conditions
Early Stage Non-small Cell Lung Cancer
Registration Number
NCT01138722
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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • Operable patient
  • > 18 years old
  • men and women
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
pathological effects of hypofractionated radiation therapyat 2 years

To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.

Secondary Outcome Measures
NameTimeMethod
clinical response ratefrom 2 to 5 years
progression free survivalfrom 2 to 5 years
overall survivalfrom 2 to 5 years
the accuracy of clinical mediastinal stagingfrom 2 to 5 years
the complication ratefrom 2 to 5 years
local, regional or distant failurefrom 2 to 5 years
disease specific overall survivalfrom 2 to 5 years

Trial Locations

Locations (2)

University Hospital Ghent

🇧🇪

Ghent, Belgium

University Hospital Antwerp

🇧🇪

Antwerp, Belgium

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