SBRT/RT in Oligometastatic Stage IV NSCLC

Launched by UNIVERSITY HOSPITAL OSTRAVA · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with Stage IV non-small cell lung cancer (NSCLC) who have a limited number of cancer sites, known as oligometastatic disease. The researchers want to find out if using a focused radiation treatment called stereotactic body radiation therapy (SBRT), followed by ongoing chemotherapy, can help patients live longer without their cancer worsening, compared to those who only receive continued chemotherapy. The trial is currently looking for participants aged 18 and older who have already received three months of initial chemotherapy and have stable or improved disease after that treatment.

To be eligible for this study, participants must have confirmed metastatic NSCLC with up to 10 active cancer spots in their body, and they should be in good overall health, as measured by a performance scale. Participants can expect to receive the SBRT treatment and then maintenance chemotherapy, with regular check-ins to monitor their health and the effectiveness of the treatment. It's important to know that individuals with certain previous treatments or health conditions may not be able to participate, so discussing eligibility with a healthcare provider is essential.

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Eligibility criteria

• Inclusion Criteria:
• • Patients must have biopsy-proven metastatic NSCLC (Stage IV).
• • Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.
• • Age ≥ 18 years
• • Patients must have measurable disease at baseline.
• • Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.
• • Patients must have a Karnofsky Performance Scale (KPS) \>60
• • AST, ALT \& Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal.
• • Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• • Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN).
• • Females of childbearing potential should have a negative pregnancy test.
• • Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
• • Patients must provide verbal and written informed consent to participate in the study
• Exclusion Criteria:
• • Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.
• • Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy
• • Patients with serious, uncontrolled, concurrent infection(s)
• • Significant weight loss (\>10%) in the prior 3 months
• • Patients with cutaneous metastasis of NSCLC
• • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers
• • Patients with more than 10 discrete extra/intracranial lesions
• • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• • Unwillingness to participate or inability to comply with the protocol for the duration of the study
• • Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Trial Officials