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Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01480973
Recruitment Status : Active, not recruiting
First Posted : November 29, 2011
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30% of all cancer deaths. The standard treatment for patients with early-stage non-small-cell lung cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients are unable to undergo such a major surgery due to medical illness, and an emerging standard-of-care for these patients stereotactic-body radiation therapy (SBRT).

SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately describe, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.


Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Radiation: Stereotactic Body Radiation Therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Assessment of Post-Radiation Change Following Stereotactic Body RT for Non-Small Cell Lung Cancer: A Pilot Study
Study Start Date : June 2011
Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: MRI post lung SBRT
Feasibility of MRI to differentiate between benign and malignant changes seen after lung SBRT.
Radiation: Stereotactic Body Radiation Therapy
SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately delineated, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.


Outcome Measures

Primary Outcome Measures :
  1. Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC. [ Time Frame: 2 years ]
    MRI pulse sequence settings

  2. MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC. [ Time Frame: 2 years ]
    MRI tissue contrast


Secondary Outcome Measures :
  1. Reliability and reproducibility of thoracic MRI to distinguish between benign (fibrosis), malignant (recurrence), and indeterminate lung changes following SBRT for early-stage NSCLC. [ Time Frame: 2 years ]
    Sensitivity, specificity, positive and negative predictive value


Eligibility Criteria

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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:

  • Must have been treated at University of Health Network with SBRT for an early-stage NSCLC (T1N0M0; T2N0M0; or T3N0M0 chest wall primary tumours only).
  • On follow-up thoracic CT scans, patients must have changes in the previously targeted lung parenchyma that fit into one of the following three patterns: - Changes that on CT and clinical grounds are felt to be related to fibrosis
  • Changes that on CT and clinical grounds are suspicious for recurrence
  • Equivocal changes (uncertain whether the changes represent fibrosis or recurrence)
  • Must be greater than 18 years in age
  • Must be able to attend regular follow-up including radiologic investigations and clinical visits
  • Written informed consent

Exclusion Criteria:

  • Standard contraindications to MRI study (e.g. ferromagnetic prosthesis, pacemaker/implanted defibrillator, metallic implant in eye, severe claustrophobia, etc…)
  • Contraindications to Gadolinium contrast-agent. May include a history of allergic reaction to following previous administration of gadolinium or poor renal function (calculated creatinine clearance < 30 mL/min).
  • Patients with surgical resection of the treated portion of lung following their SBRT, although surgical resection of other parts of the lung is allowed.
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): NCT01480973


Locations
Canada, Ontario
Princess Margaret Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01480973     History of Changes
Other Study ID Numbers: UHN REB 11-0079-CE
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

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