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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01480973
First received: August 16, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Non Small Cell Lung Cancer
Radiation: Stereotactic Body Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    MRI pulse sequence settings

  • MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    MRI tissue contrast


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Sensitivity, specificity, positive and negative predictive value


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01480973

Contacts
Contact: John Cho 416-946-4501 ext 2124 john.cho@rmp.uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John Cho, MD    416-946-4501 ext 2124    john.cho@rmp.uhn.on.ca   
Principal Investigator: John Cho, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01480973     History of Changes
Other Study ID Numbers: UHN REB 11-0079-CE
Study First Received: August 16, 2011
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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 28, 2014