Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · May 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called stereotactic ablative radiotherapy (SABR) for patients with a specific type of lung cancer known as metastatic non-small cell lung cancer (NSCLC) that is showing limited progression. In this trial, 68 participants who have up to five small tumor spots outside of their original lung cancer site will be randomly assigned to either receive standard care (which may involve switching to a different medication or continuing their current treatment) or to receive SABR to target those tumor spots while continuing their current treatment. The goal is to see if the SABR treatment can help control the cancer better than standard care alone.

To be eligible for this trial, participants must be at least 18 years old and have metastatic NSCLC that has shown limited growth, meaning they have 1 to 5 small tumors outside of the lungs that are 5 cm or smaller. They should also be able to provide consent to participate and have a good level of health, as indicated by their performance status. Patients with brain metastases can participate, but those with larger tumors or certain medical conditions that could interfere with treatment are not eligible. Participants in the study will be monitored closely, and their experience will help researchers understand the effectiveness of SABR as a treatment option for this type of lung cancer.

Gender

ALL

Eligibility 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)