Study on Avoiding Radiation Therapy for Brain Metastases Responding to Chemotherapy, Targeted Therapy, or Immunotherapy

Sponsor: University of Vermont Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06974370

Provider View

This clinical trial is exploring whether patients with brain metastases who respond well to systemic treatments like chemotherapy, targeted therapy, or immunotherapy can safely avoid radiation therapy. The study will include 45 participants with brain metastases from non-small cell lung cancer or other solid tumors.

Patient Parameters

Program Overview

The aim of this study is to see if patients with brain metastases who show a positive response to treatments such as chemotherapy, targeted therapy, or immunotherapy can avoid radiation therapy. The trial will involve 45 patients, with 30 having non-small cell lung cancer (NSCLC) and 15 having brain metastases from other cancers. Participants must have at least one brain metastasis that is not planned for radiation or surgery and must be starting a treatment expected to work in the brain. After starting treatment, patients will have a brain MRI in 4-8 weeks. If the brain lesions are stable or shrinking, they will continue without radiation. If the cancer progresses, radiation may be given. The main goal is to see how many NSCLC patients can avoid radiation for six months based on their PD-L1 status. Other goals include tracking cancer progression, survival rates, and quality of life.

Description

This study is testing if patients with brain metastases who respond to systemic treatments can avoid radiation therapy. It will include 45 patients, with 30 having non-small cell lung cancer (NSCLC) and 15 having brain metastases from other cancers. Participants must have at least one brain metastasis not planned for radiation or surgery and must be starting a treatment expected to work in the brain. After starting treatment, patients will have a brain MRI in 4-8 weeks. If the brain lesions are stable or shrinking, they will continue without radiation. If the cancer progresses, radiation may be given. The main goal is to see how many NSCLC patients can avoid radiation for six months based on their PD-L1 status. Other goals include tracking cancer progression, survival rates, and quality of life.

Brain metastases are common in cancer patients and are usually treated with surgery and radiation. However, radiation can cause cognitive decline, especially in patients expected to live longer. New treatments like immunotherapy and targeted therapy have shown promise in treating brain metastases, especially in NSCLC. This study will help determine if delaying or avoiding radiation is safe for patients responding to these treatments. Participants will have regular MRIs to monitor their condition and will receive radiation if their cancer progresses. The study will provide valuable information for future research and help identify patients who can safely avoid radiation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with a solid tumor cancer within the last 5 years, or have recent confirmation of cancer spread if diagnosed earlier.
  • Starting or planning to start a systemic treatment expected to work in the brain, such as targeted therapies, immunotherapy, or certain chemotherapy drugs.
  • Have at least one brain metastasis not planned for radiation or surgery.
  • All brain metastases not planned for surgery must be 3 cm or smaller.
  • Systemic therapy must start within 4 weeks of a brain MRI showing new or worsening disease.
  • Able to have MRI scans with contrast.
  • Age 18 or older.
  • Have a Karnofsky Performance Status (KPS) score over 60, indicating the ability to care for oneself.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have not used the planned new systemic therapy for brain metastases in the last 6 months.
  • Have had prior radiation to the active brain metastases.
  • Pregnant or nursing individuals due to potential risks to the baby.
  • Have serious medical conditions that would prevent participation.
  • Have known leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).

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