Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial (PEARL-1)

This study has been terminated.

(Poor recruitment rate.)

Sponsor:

Collaborator:

Nationaal Kankerplan

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01138722

First received: June 4, 2010

Last updated: August 24, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 4, 2010

Last Updated Date

August 24, 2011

Start Date ^ICMJE

May 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pathological effects of hypofractionated radiation therapy [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.

Original Primary Outcome Measures ^ICMJE

Rate of pCR [ Time Frame: at 2 year ] [ Designated as safety issue: No ]
RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. Immunohistochemical analysis of the resection specimen at time of surgery

After completion of the study treatment, patients are followed periodically for 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. Immunohistochemical analysis of the resection specimen at time of surgery

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

Change History

Complete list of historical versions of study NCT01138722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

clinical response rate [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]
the accuracy of clinical mediastinal staging [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]
the 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 ]
overall survival [ Time Frame: from 2 to 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

clinical response 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, at end of Radiation, EOT and every visit until 24M
the accuracy of clinical mediastinal staging [ Designated as safety issue: No ]
RX at screening, EOT, 3M,6M ,9M ,12M ,18M, 24M. FACT-L questionnaire at screening, at end of Radiation, EOT and every visit until 24M
the completion rate [ 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, at end of Radiation, 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, at end of Radiation, 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, at end of Radiation, 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, at end of Radiation, 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, at end of Radiation, EOT and every visit until 24M
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, at end of Radiation, 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

Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial

Official Title ^ICMJE

Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer

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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

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

Early Stage Non-small Cell Lung Cancer

Intervention ^ICMJE

Radiation: hypofractionated radiation therapy followed by surgery

hypofractionated radiation therapy followed by surgery

Study Arm (s)

Not Provided

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

Estimated Completion Date

May 2017

Primary Completion Date

August 2011 (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
Operable patient
> 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

NCT01138722

Other Study ID Numbers ^ICMJE

2010/204, 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, Belgium

Information Provided By

University Hospital, Ghent

Verification Date

August 2011

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

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