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

Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01138722
Acronym
PEARL-1
Enrollment
1
Registered
2010-06-07
Start date
2010-05-31
Completion date
2011-08-31
Last updated
2021-07-08

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

Conditions

Early Stage Non-small Cell Lung Cancer

Keywords

early stage non-small cell lung cancer, hypofractionated 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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

Interventions

RADIATIONhypofractionated radiation therapy followed by surgery

hypofractionated radiation therapy followed by surgery

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 * Operable patient * \> 18 years old * men and women

Design outcomes

Primary

MeasureTime frameDescription
pathological effects of hypofractionated radiation therapyat 2 yearsTo describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.

Secondary

MeasureTime frame
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
clinical response ratefrom 2 to 5 years
disease specific overall survivalfrom 2 to 5 years
overall survivalfrom 2 to 5 years
progression free survivalfrom 2 to 5 years

Countries

Belgium

Outcome results

None listed

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