Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers (PEARL-2)

Ghent University Hospital (UZ)

Status and phase: Terminated; Phase 2

Conditions: Inoperable Early Stage Non-small Cell Lung Cancer

Treatments: Radiation: hypofractionated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01138748

LONG 10-01 (Other Identifier)

2010/205

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Radiation therapy

Experimental group

Treatment:

Radiation: hypofractionated radiation therapy