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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention Phase
Peripherally Located Stage I Lung Cancer
Peripherally Located Solitary Lung Metastasis
Radiation: Stereotactic Body Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: May 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Sunnybrook Odette Cancer Centre
  More Information

No publications provided

Responsible Party: Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01620034     History of Changes
Other Study ID Numbers: 106-2010
Study First Received: June 11, 2012
Last Updated: June 14, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on November 23, 2014