Overview

This trial is active, not recruiting.

Conditions peripherally located stage i lung cancer, peripherally located solitary lung metastasis
Treatment stereotactic body radiotherapy
Phase phase 2
Sponsor Sunnybrook Health Sciences Centre
Start date May 2010
End date August 2012
Trial size 50 participants
Trial identifier NCT01620034, 106-2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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)
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 Outcomes

Measure
Rate of grade 2 or higher acute toxicity
time frame: Within 4 months after completion of therapy

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days
Principal investigator Patrick Cheung, MD, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre.