Study on Stereotactic Radiosurgery for Treating Brain Metastasis in Small Cell Lung Cancer Patients

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04516070

Provider View

This clinical trial is exploring how a precise form of radiation therapy, called stereotactic radiosurgery, affects brain function in patients with small cell lung cancer that has spread to the brain. The study aims to see if this targeted approach can reduce side effects compared to traditional whole brain radiation therapy.

Patient Parameters

Program Overview

This study is investigating the effects of stereotactic radiosurgery (SRS) on brain function in patients with small cell lung cancer that has spread to the brain. Unlike whole brain radiation therapy, which targets the entire brain and can cause nervous system side effects, SRS focuses only on specific areas affected by cancer. The goal is to determine if SRS can help patients avoid these side effects while effectively managing brain metastasis.

Description

The main goal of this study is to estimate how often patients experience cognitive decline, or a decrease in brain function, three months after treatment with stereotactic radiosurgery (SRS). Researchers will also look at cognitive changes over time using different tests and methods.

Other objectives include:

  • Monitoring overall survival rates of patients receiving SRS for brain metastasis from small cell lung cancer.
  • Evaluating how well the treated brain tumors are controlled after SRS, using MRI scans.
  • Assessing the control of untreated brain tumors and the time until whole brain radiation therapy is needed.
  • Reporting any side effects in the brain from SRS, especially in patients who have had previous whole brain radiation therapy.
  • Investigating the effects of combining SRS with the immunotherapy drug atezolizumab.
  • Determining how long patients live without their cancer progressing, both in the brain and throughout the body.
  • Analyzing factors that might predict treatment success and cognitive outcomes.
  • Studying the relationship between the number and size of brain tumors and cognitive function.
  • Documenting any side effects in the brain after SRS treatment.

Patients will undergo SRS unless their disease worsens or they experience unacceptable side effects. If the cancer progresses, additional SRS treatments may be considered. After treatment, patients will have follow-up visits at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months to monitor their health and treatment effects.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 3 or less, indicating the ability to carry out daily activities with some limitations.
  • Must have a confirmed diagnosis of small cell lung cancer, based on tissue samples from the primary tumor or another metastatic site.
  • Must have 10 or fewer brain metastases visible on a brain MRI scan taken within 6 weeks before joining the study. A biopsy of brain metastases is not required.
  • Must be eligible for stereotactic radiosurgery for all brain lesions, as determined by the study's radiation oncologist.
  • Must sign an informed consent form acknowledging the investigational nature of the study.
  • Must have normal blood clotting ability, with an INR less than 1.3, within 28 days of joining the study.
  • Must speak English as their primary language.
  • Must not have had any previous radiation therapy to the brain, including whole brain radiation therapy, prophylactic cranial irradiation, or stereotactic radiosurgery.
  • Must have a performance status assessment conducted by the treating physician.

Exclusion Criteria

  • Cannot have a history of other metastatic cancers besides small cell lung cancer or uncontrolled non-metastatic cancer. Localized squamous or basal cell skin cancers are exceptions.
  • Cannot have evidence of cancer spread to the membranes covering the brain and spinal cord, as seen on imaging tests.
  • Cannot have cancer cells found in the cerebrospinal fluid.
  • Cannot be pregnant or breastfeeding if they are of childbearing age.
  • Cannot have allergies to MRI contrast agents or other reasons preventing an MRI scan.
  • Cannot have a history of psychiatric or neurological illnesses, or other conditions affecting cognitive function, unless related to brain metastasis.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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