Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01480973
First received: August 16, 2011
Last updated: December 17, 2012
Last verified: December 2012
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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
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: | December 17, 2012 |
| Health Authority: | 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 May 21, 2013