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

Not Applicable

Completed

• Conditions: Peripherally Located Stage I Lung Cancer; Peripherally Located Solitary Lung Metastasis
• Interventions: Radiation: Stereotactic Body Radiotherapy

• Registration Number: NCT01620034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Primary Completion: 2012-08
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
11 Day Arm	Stereotactic Body Radiotherapy	-
4 Day Arm	Stereotactic Body Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Rate of grade 2 or higher acute toxicity	Within 4 months after completion of therapy	CTCAE v4.0 will be used to capture radiotherapy toxicity.

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada