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

Tracking Information

First Received Date ^ICMJE

June 4, 2010

Last Updated Date

February 1, 2013

Start Date ^ICMJE

November 2010

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01138748 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Inoperable Early Stage Non-small Cell Lung Cancer

Intervention ^ICMJE

Radiation: hypofractionated radiation therapy

hypofractionated radiation therapy

Study Arm (s)

Experimental: Radiation therapy

Intervention: Radiation: hypofractionated radiation therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01138748

Other Study ID Numbers ^ICMJE

2010/205, LONG 10-01

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Nationaal Kankerplan

Investigators ^ICMJE

Principal Investigator:

Jan Van Meerbeeck, MD,PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

February 2013

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

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