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

Inoperable Early Stage Non-small Cell Lung Cancer Clinical Trial

— PEARL-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01138748
• Other study ID #: 2010/205
• Secondary ID: LONG 10-01
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2010
• Last updated: February 1, 2013
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Proof of cT1a/b - 2a/b N0M0 NSCLC

• Informed Consent signed

• Resectable tumour

• > 18 years old

• men and women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inoperable Early Stage Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• hypofractionated radiation therapy
hypofractionated radiation therapy

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Nationaal Kankerplan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development and validation of a multi-variate predictive model	To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.	from 2 to 5 years	No
Secondary	the clinical response and complication rate		from 2 to 5 years	No
Secondary	local, regional or distant failure		from 2 to 5 years	No
Secondary	progression free survival		from 2 to 5 years	No
Secondary	disease specific overall survival		from 2 to 5 years	No

External Links

•   Website of University Hospital Ghent