Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days
Primary Purpose
Peripherally Located Stage I Lung Cancer, Peripherally Located Solitary Lung Metastasis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Peripherally Located Stage I Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Pathologic diagnosis of malignancy in the lung (either NSCLC or metastasis)
- If pathologic diagnosis is not available, there must be evidence of FDG uptake on PET-CT suggestive of malignancy and/or evidence of tumour growth over serial CT scans
- Clinical stage I lung cancer or solitary lung metastasis located in the periphery away from central mediastinal structures and <=5cm in size
- Patient deemed suitable for lung SBRT (reasonable performance status, acceptable pulmonary function) by the attending Radiation Oncologist
Sites / Locations
- Sunnybrook Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
11 Day Arm
4 Day Arm
Arm Description
Outcomes
Primary Outcome Measures
Rate of grade 2 or higher acute toxicity
CTCAE v4.0 will be used to capture radiotherapy toxicity.
Secondary Outcome Measures
Full Information
NCT ID
NCT01620034
First Posted
June 11, 2012
Last Updated
May 3, 2018
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01620034
Brief Title
Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days
Official Title
A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally located lung tumours, offering very high rates of tumour eradication, with minimal side effects. Even though this treatment option is being adopted in more and more cancer centres, there is still no consensus about the optimal schedule for the radiation treatment. Generally speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over 11 days (each treatment given once very 3rd day). However, some centres deliver the same treatment over 4 days in a row (each treatment given once daily over 4 days). There is no evidence from the published literature to suggest that there is any difference in side effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the investigators propose to conduct a comparative (randomized) study to compare these 2 approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripherally Located Stage I Lung Cancer, Peripherally Located Solitary Lung Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11 Day Arm
Arm Type
Active Comparator
Arm Title
4 Day Arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
Patients on the 11 day arm receive 4 fractions of SBRT every 3rd day. Patients on the 4 day arm receive 4 fractions of SBRT every day.
Primary Outcome Measure Information:
Title
Rate of grade 2 or higher acute toxicity
Description
CTCAE v4.0 will be used to capture radiotherapy toxicity.
Time Frame
Within 4 months after completion of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologic diagnosis of malignancy in the lung (either NSCLC or metastasis)
If pathologic diagnosis is not available, there must be evidence of FDG uptake on PET-CT suggestive of malignancy and/or evidence of tumour growth over serial CT scans
Clinical stage I lung cancer or solitary lung metastasis located in the periphery away from central mediastinal structures and <=5cm in size
Patient deemed suitable for lung SBRT (reasonable performance status, acceptable pulmonary function) by the attending Radiation Oncologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Cheung, MD, FRCPC
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days
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