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

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ClinicalTrials.gov Identifier: NCT01620034
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Peripherally Located Stage I Lung Cancer Peripherally Located Solitary Lung Metastasis Radiation: Stereotactic Body Radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days
Actual Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 11 Day Arm 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.
Experimental: 4 Day Arm 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.



Primary Outcome Measures :
  1. Rate of grade 2 or higher acute toxicity [ Time Frame: Within 4 months after completion of therapy ]
    CTCAE v4.0 will be used to capture radiotherapy toxicity.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620034


Locations
Canada, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Patrick Cheung, MD, FRCPC Toronto Sunnybrook Regional Cancer Centre

Responsible Party: Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01620034     History of Changes
Other Study ID Numbers: 106-2010
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018