This phase 3 trial aims to compare the effectiveness of stereotactic body radiotherapy with conventional radiotherapy in patients with early stage non-small-cell lung cancer (NSCLC) that cannot undergo surgery for medical reasons. The main outcome of the trial will be absence of local recurrence (whether the cancer has come back at or near the original site). The trial will take place in 16-20 clinics across Canada.
The details
Conventional radiotherapy involves small doses of radiation daily over the course of several weeks. Stereotactic body radiotherapy (SBRT) is a method that pinpoints the exact location of the tumor, and high doses of radiation are delivered to that area. SBRT involves fewer treatments than conventional radiotherapy.
This trial will assess which method is more effective at treating NSCLC that cannot be surgically removed. It will also examine which method has lower toxicity. To measure the trial outcomes, the participants will undergo regular check-ups for 5 years following treatment to examine whether the tumor has recurred, any side effects and participant survival.
Who are they looking for?
The trial is recruiting 324 people with stage 1 NSCLC, who are medically unable to undergo surgery as treatment for the cancer. Participants must be available for treatment and regular checkups in the clinics in Canada.
Pregnant or breastfeeding women will be excluded from this trial. Participants with idiopathic pulmonary fibrosis (a lung disease) or ataxia telangiectasia (a neurodegenerative disorder) cannot partake in the trial. Participants must not have had prior radiotherapy near the site of the current tumor. Participants must not have had invasive malignancy (cancer that is growing into surrounding tissue) in the past 5 years before beginning the trial.
How will it work
Participants will be randomly assigned to one of two groups. Ong group will be treated with stereotactic body radiotherapy, while the other group will be treated with conventional radiotherapy. Participants will then have regular checkups to see if the cancer has come back, to assess treatment related side effects, and to monitor participant survival. These follow-ups will go on until 5 years after treatment.
