Trial Information
A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of grade 2 or higher acute toxicity
Outcome Description:
CTCAE v4.0 will be used to capture radiotherapy toxicity.
Outcome Time Frame:
Within 4 months after completion of therapy
Safety Issue:
Yes
Principal Investigator
Patrick Cheung, MD, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sunnybrook Odette Cancer Centre
Authority:
Canada: Health Canada
Study ID:
106-2010
NCT ID:
NCT01620034
Start Date:
May 2010
Completion Date:
Related Keywords:
- Peripherally Located Stage I Lung Cancer
- Peripherally Located Solitary Lung Metastasis
- Lung Neoplasms
- Neoplasm Metastasis