Stereotactic body radiotherapy for the treatment of OPD

Current primary outcome measures as of 25/10/2021:
Progression-free survival defined as the time from randomisation to the first of one of the following events or death from any cause:
1.1. Clinically symptomatic progression requiring palliative tumour-specific oncological intervention (e.g. change in systemic therapy or localised non-SBRT radiotherapy) as determined by the treating physician
1.2. New or existing intra-cranial lesions not amenable to radical surgery or SRS
1.3. Development of new extra-cranial lesions or progression of existing extra-cranial lesions not meeting the criteria for SBRT treatment (e.g. size >7 cm)
1.4. Development of >5 new or progressing extra-cranial lesion at any one point in time (i.e. widespread progression)

Previous primary outcome measures:
Progression-free survival defined as the time from randomisation to the first of one of the following events or death from any cause:
1.1. Clinically symptomatic progression requiring palliative tumour-specific oncological intervention (e.g. change in systemic therapy or localised non-SBRT radiotherapy) as determined by the treating physician.
1.2. New or existing intra-cranial lesions not amenable to radical surgery or SRS.
1.3. Development of new extra-cranial lesions or progression of existing extra-cranial lesions not meeting the criteria for SBRT treatment (e.g. size >5cm)
1.4. Development of >3 new or progressing extra-cranial lesion at any one point in time (i.e. widespread progression)

Current secondary outcome measures as of 25/10/2021:
1. Time to next line of systemic therapy or palliative care – time from randomisation to change in therapy or referral to palliative care due to clinical progression as determined by the treating physician, or death.
2. Overall survival is measured from the time of randomisation until death from any cause.
3. Patterns of disease progression are identified using CT scans to further document natural history of oncogene-addicted NSCLC at 3 monthly intervals.
4. Radiotherapy toxicities (acute and late) assessed using CTCAE v4.0 (clinician and patient versions where available). Acute events are defined as ≤90 days post SBRT start date (applicable for each subsequent course of SBRT where relevant); late events > 90 days.
5. Quality of Life is assessed using EQ-5D-5L and the EORTC QLQ-C30 at baseline, 8 weeks and at the first 3-month visit.
6. Measurement of resistant sub-clones in ctDNA is from blood samples collected at baseline, 8 weeks post-randomisation and 3-monthly during follow-up.
7. Time to failure of next line treatment is measured from the time of randomisation to disease progression on the next line of active systemic therapy.

Previous secondary outcome measures:
1. Time to next line of systemic therapy or palliative care – time from randomisation to change in therapy or referral to palliative care due to clinical progression as determined by the treating physician, or death.
2. Overall survival is measured from the time of randomisation until death from any cause.
3. Patterns of disease progression are identified using CT scans to further document natural history of oncogene-addicted NSCLC at 3 monthly intervals
4. Radiotherapy toxicities (acute and late) assessed using CTCAE v4.0 (clinician and patient versions (where available)) and RTOG. Acute events are defined as ≤ 90 days post SBRT start date (applicable for each subsequent course of SBRT where relevant); late events > 90 days.
5. Quality of Life is assessed using EQ-5D-5L and the EORTC QLQ-C30 at baseline, 8 weeks and at the first 3-month visit
6. Measurement of resistant sub-clones in ctDNA is from blood samples collected at baseline, 8 weeks post-randomisation and 3-monthly during follow-up
7. Time to failure of next line treatment is measured from the time of randomisation to disease progression on the next line of active systemic therapy