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

Peripherally Located Solitary Lung Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620034
• Other study ID #: 106-2010
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripherally Located Solitary Lung Metastasis
• Peripherally Located Stage I Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of grade 2 or higher acute toxicity	CTCAE v4.0 will be used to capture radiotherapy toxicity.	Within 4 months after completion of therapy