search
Back to results

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

Primary Purpose

Early Stage Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
hypofractionated radiation therapy followed by surgery
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Non-small Cell Lung Cancer focused on measuring early stage non-small cell lung cancer, hypofractionated radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • University Hospital Antwerp
  • University Hospital Ghent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

clinical response rate
the accuracy of clinical mediastinal staging
the complication rate
local, regional or distant failure
progression free survival
disease specific overall survival
overall survival

Full Information

First Posted
June 4, 2010
Last Updated
July 7, 2021
Sponsor
University Hospital, Ghent
Collaborators
Nationaal Kankerplan
search

1. Study Identification

Unique Protocol Identification Number
NCT01138722
Brief Title
Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial
Acronym
PEARL-1
Official Title
Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment rate.
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Nationaal Kankerplan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Non-small Cell Lung Cancer
Keywords
early stage non-small cell lung cancer, hypofractionated radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy followed by surgery
Intervention Description
hypofractionated radiation therapy followed by surgery
Primary Outcome Measure Information:
Title
pathological effects of hypofractionated radiation therapy
Description
To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
clinical response rate
Time Frame
from 2 to 5 years
Title
the accuracy of clinical mediastinal staging
Time Frame
from 2 to 5 years
Title
the complication rate
Time Frame
from 2 to 5 years
Title
local, regional or distant failure
Time Frame
from 2 to 5 years
Title
progression free survival
Time Frame
from 2 to 5 years
Title
disease specific overall survival
Time Frame
from 2 to 5 years
Title
overall survival
Time Frame
from 2 to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proof of cT1a/b - 2a/b N0M0 NSCLC Informed Consent signed Resectable tumour Operable patient > 18 years old men and women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Van Meerbeeck, MD, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website of University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs