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

Early Stage Non-small Cell Lung Cancer

Intervention / Treatment

Radiation: hypofractionated radiation therapy followed by surgery

Study Type

Interventional

Enrollment (Actual)

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

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

website of University Hospital Ghent

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