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 range18 Years
SexALL
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).
✓. 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.
✕
What they're measuring
1
Overall Survival
Timeframe: From date of randomisation to the date of death, up to 36 months
✕. 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.