Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01620034
First received: June 11, 2012
Last updated: June 14, 2012
Last verified: June 2012

June 11, 2012
June 14, 2012
May 2010
August 2012   (final data collection date for primary outcome measure)
Rate of grade 2 or higher acute toxicity [ Time Frame: Within 4 months after completion of therapy ] [ Designated as safety issue: Yes ]
CTCAE v4.0 will be used to capture radiotherapy toxicity.
Same as current
Complete list of historical versions of study NCT01620034 on ClinicalTrials.gov Archive Site
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Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days
A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripherally Located Stage I Lung Cancer
  • Peripherally Located Solitary Lung Metastasis
Radiation: Stereotactic Body Radiotherapy
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.
  • Active Comparator: 11 Day Arm
    Intervention: Radiation: Stereotactic Body Radiotherapy
  • Experimental: 4 Day Arm
    Intervention: Radiation: Stereotactic Body Radiotherapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01620034
106-2010
No
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Patrick Cheung, MD, FRCPC Sunnybrook Odette Cancer Centre
Sunnybrook Health Sciences Centre
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP