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Clinical Trials/NCT01620034
NCT01620034
Completed
N/A

A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days

Sunnybrook Health Sciences Centre1 site in 1 country50 target enrollmentMay 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripherally Located Stage I Lung Cancer
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
50
Locations
1
Primary Endpoint
Rate of grade 2 or higher acute toxicity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Patrick Cheung

Radiation Oncologist

Sunnybrook Health Sciences Centre

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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