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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 24, 2014