Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
Nationaal Kankerplan
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: June 4, 2010
Last updated: February 1, 2013
Last verified: February 2013

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

Condition Intervention Phase
Inoperable Early Stage Non-small Cell Lung Cancer
Radiation: hypofractionated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • development and validation of a multi-variate predictive model [ Time Frame: from 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:
  • the clinical response and complication rate [ Time Frame: from 2 to 5 years ]
  • local, regional or distant failure [ Time Frame: from 2 to 5 years ]
  • progression free survival [ Time Frame: from 2 to 5 years ]
  • disease specific overall survival [ Time Frame: from 2 to 5 years ]

Enrollment: 5
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation therapy Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • > 18 years old
  • men and women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01138748

University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Nationaal Kankerplan
Principal Investigator: Jan Van Meerbeeck, MD,PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT01138748     History of Changes
Other Study ID Numbers: 2010/205
LONG 10-01 ( Other Identifier: University Hospital Ghent )
Study First Received: June 4, 2010
Last Updated: February 1, 2013

Keywords provided by University Hospital, Ghent:
inoperable early stage non-small cell lung cancer
radiation therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on April 28, 2017