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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
  Purpose

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.


Condition Intervention Phase
Early Stage Non-small Cell Lung Cancer
 Radiation: hypofractionated radiation therapy followed by surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: May 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: hypofractionated radiation therapy followed by surgery
    hypofractionated radiation therapy followed by surgery
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • Operable patient
  • > 18 years old
  • men and women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138722

Locations
Belgium
University Hospital Antwerp
Antwerp, Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Nationaal Kankerplan
Investigators
Principal Investigator: Jan Van Meerbeeck, MD, PhD University Hospital Ghent, Belgium
  More Information

Additional Information:
website of University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138722     History of Changes
Other Study ID Numbers: 2010/204, LONG 10-01
Study First Received: June 4, 2010
Last Updated: August 24, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
early stage non-small cell lung cancer
hypofractionated radiation therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013