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

July 7, 2021 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • University Hospital Antwerp
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological effects of hypofractionated radiation therapy
Time Frame: at 2 years
To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.
at 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
local, regional or distant failure
Time Frame: from 2 to 5 years
from 2 to 5 years
progression free survival
Time Frame: from 2 to 5 years
from 2 to 5 years
disease specific overall survival
Time Frame: from 2 to 5 years
from 2 to 5 years
clinical response rate
Time Frame: from 2 to 5 years
from 2 to 5 years
the accuracy of clinical mediastinal staging
Time Frame: from 2 to 5 years
from 2 to 5 years
the complication rate
Time Frame: from 2 to 5 years
from 2 to 5 years
overall survival
Time Frame: from 2 to 5 years
from 2 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Nationaal Kankerplan

Investigators

  • Principal Investigator: Jan Van Meerbeeck, MD, PhD, University Hospital Ghent, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/204
  • LONG 10-01 (Other Identifier: University Hospital Ghent)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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