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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.
Sponsor:
Collaborator:
Nationaal Kankerplan
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01138748
First received: June 4, 2010
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • local, regional or distant failure [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]
  • disease specific overall survival [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Website of University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138748     History of Changes
Other Study ID Numbers: 2010/205, LONG 10-01
Study First Received: June 4, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013