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

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ClinicalTrials.gov Identifier: NCT01138748
Recruitment Status : Terminated
First Posted : June 7, 2010
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Nationaal Kankerplan
Information provided by (Responsible Party):
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 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 or disease Intervention/treatment Phase
Inoperable Early Stage Non-small Cell Lung Cancer Radiation: hypofractionated radiation therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Radiation therapy Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy



Primary Outcome Measures :
  1. 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 :
  1. the clinical response and complication rate [ Time Frame: from 2 to 5 years ]
  2. local, regional or distant failure [ Time Frame: from 2 to 5 years ]
  3. progression free survival [ Time Frame: from 2 to 5 years ]
  4. disease specific overall survival [ Time Frame: from 2 to 5 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138748


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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138748     History of Changes
Other Study ID Numbers: 2010/205
LONG 10-01 ( Other Identifier: University Hospital Ghent )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms