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

June 4, 2010
February 1, 2013
November 2010
October 2012   (final data collection date for primary outcome measure)
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.
Progression free survival (PFS) [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M.

After completion of the study treatment, patients are followed periodically for 5 years

Complete list of historical versions of study NCT01138748 on ClinicalTrials.gov Archive Site
  • 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 ]
  • the completion rate [ Time Frame: until 2 years ] [ Designated as safety issue: No ]
    RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, EOT and every visit until 24M
  • quality of life [ Time Frame: until 2 years ] [ Designated as safety issue: No ]
    RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, EOT and every visit until 24M
  • local, regional or distant failure [ Time Frame: until 2 years ] [ Designated as safety issue: No ]
    RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, EOT and every visit until 24M
  • disease free survival [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, EOT and every visit until 24M
  • disease specific overall survival [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, EOT and every visit until 24M
Not Provided
Not Provided
 
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Inoperable Early Stage Non-small Cell Lung Cancer
Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy
Experimental: Radiation therapy
Intervention: Radiation: hypofractionated radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • > 18 years old
  • men and women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01138748
2010/205, LONG 10-01
No
University Hospital, Ghent
University Hospital, Ghent
Nationaal Kankerplan
Principal Investigator: Jan Van Meerbeeck, MD,PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP