Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer (NCT02417662) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer
United Kingdom140 participantsStarted 2016-08-19
Plain-language summary
The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard anti-cancer therapy (SACT) in patients with oligometastatic non-small cell lung cancer. Patients will be randomised to receive either standard treatment alone (SACT) or standard treatment with conventional radiotherapy (RT) and SABR.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient ≥ 18 years
. Histologically or cytologically confirmed NSCLC.
. Staging with FDG PET-CT whole body scan and MRI brain within 45 days prior to registration (but prior to commencement of first cycle of SACT). \[Note: Brain CT with IV contrast can be performed instead (within 45 days prior to registration). However, if brain metastases are evident on the brain CT then a brain MRI must be performed prior to randomisation, i.e. the Brain CT is sufficient for registration into the trial but not for randomisation if it is positive for brain metastases, in which case a brain MRI must be performed\]
. ECOG performance status 0 to 1 (prior to commencement of first cycle of SACT).
. Patient presenting with primary disease +/- lymph nodes and synchronous oligometastatic disease (1-5 lesions in up to a maximum of 3 organs).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: From date of randomisation to the date of death, up to 36 months
. Patient is deemed fit to receive 12 weeks of induction systemic anti-cancer therapy, according to local guidelines and assessment.
. Patient is deemed fit to receive radical RT (either conventional RT or SABR) to primary disease +/- lymph node and SABR/SRS to 1-5 metastases according to local guidelines and assessment.
. Primary tumour +/- lymph node suitable for radical RT (either conventional RT or SABR).
Exclusion criteria
. Patient has had palliative radiotherapy to any tumour site prior to registration or requires palliative radiotherapy prior to randomisation.
. Presence of an actionable molecular aberration.
. Patients currently receiving VEGF inhibitors.
. One or more metastases previously treated with alternative ablative treatment.Note: Surgical ablation (partial or total excision biopsy) is permitted for palliative or diagnostic purposes (e.g. for molecular analysis). Treatment for any residual disease/tumour bed will be at the discretion of treating clinician/MDT. Resected/ablated metastases will count towards the total number of metastases.
. Patient has received any previous treatment for this NSCLC malignancy.
. Patients who present with brain metastasis only and no sites of extra cranial metastatic disease i.e. the presence of more than 4 brain metastases is an exclusion criterion.
. Metastasis in sites where normal radiotherapy OAR constraints cannot be met.