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

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ClinicalTrials.gov Identifier: NCT01138722
Recruitment Status : Terminated (Poor recruitment rate.)
First Posted : June 7, 2010
Last Update Posted : August 25, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
Study Start Date : May 2010
Primary Completion Date : August 2011
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Intervention Details:
    Radiation: hypofractionated radiation therapy followed by surgery
    hypofractionated radiation therapy followed by surgery

Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. clinical response rate [ Time Frame: from 2 to 5 years ]
  2. the accuracy of clinical mediastinal staging [ Time Frame: from 2 to 5 years ]
  3. the complication rate [ Time Frame: from 2 to 5 years ]
  4. local, regional or distant failure [ Time Frame: from 2 to 5 years ]
  5. progression free survival [ Time Frame: from 2 to 5 years ]
  6. disease specific overall survival [ Time Frame: from 2 to 5 years ]
  7. overall survival [ Time Frame: from 2 to 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138722     History of Changes
Other Study ID Numbers: 2010/204
LONG 10-01 ( Other Identifier: University Hospital Ghent )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011

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

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