Lung cancer Cancer Lung cancer
Conditions
Interventions
Current interventions as of 25/10/2021:
Eligible participants are randomised to receive either Stereotactic Body Radiotherapy (SBRT) or no SBRT at a ratio of 2:1 (SBRT : no SBRT), with all participant
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/10/2021: 1. Male or female, =16 years of age 2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy 3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI) 4. Confirmed OPD defined as =5 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document. 5. Adequate baseline organ function to allow SBRT to all relevant targets 6. Predicted life expectancy =6 months 7. Karnofsky Index =60% and ECOG 0-2 8. Provision of written informed consent Previous inclusion criteria: 1. Male or female, =16 years of age 2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy 3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI) 4. Confirmed OPD defined as =3 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document. 5. Adequate baseline organ function to allow SBRT to all relevant targets 6. Predicted life expectancy =6 months 7. Karnofsky Index =60% and ECOG 0-2 8. Provision of written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/10/2021: 1. >5 extracranial sites of progressive disease 2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or SRS. Previously treated brain metastases (i.e palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for =6 months are permissible. 3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT 4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node 5. Any psychological, sociological or geographical issue potentially hampering compliance with the study 6. Pregnancy Previous exclusion criteria: 1. >3 extracranial sites of progressive disease 2. Brain metastases not amenable to radical surgery or SRS 3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT 4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node 5. Any psychological, sociological or geographical issue potentially hampering compliance with the study 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, France, Italy, Spain, Switzerland, United Kingdom
Contacts
Public ContactSteven Penegar
Outcome results
None listed