Stereotactic Ablative Radiotherapy for Oligo-Progressive Lung Cancer
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial
This study is testing if a special type of targeted radiation therapy can help people with non-small cell lung cancer who have a few growing tumors while they continue their usual treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04405401 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of stereotactic ablative radiotherapy (SABR) in patients with metastatic non-small cell lung cancer (NSCLC) who are experiencing oligoprogression, defined as having 1-5 extracranial lesions. Participants will be randomized to either receive SABR to their oligoprogressive lesions while continuing their current systemic therapy or to follow standard care options as determined by their physician. The trial aims to assess whether SABR can improve outcomes compared to standard treatment approaches in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic NSCLC experiencing oligoprogression to 1-5 extracranial lesions.
Not a fit: Patients with extensive metastatic disease beyond the defined oligoprogressive lesions or those not on systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that improves outcomes for patients with oligoprogressive metastatic lung cancer.
How similar studies have performed: Other studies have shown promising results with stereotactic ablative radiotherapy in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry * Ability to provide written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis. * Oligoprogression while on ICI or TKI (any line) * Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care * All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.) * Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible. Exclusion Criteria: * Any lesion beyond 5 cm * Pregnancy or breastfeeding * Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy. * Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Silvine Benth
- Email: silvine.benth.chum@ssss.gouv.qc.ca
- Phone: 514-890-8254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.