Clinical trial NCT05692635: Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Official title: Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Metastases
Nonsmall Cell Lung Cancer Stage III
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.

Detailed description: Primary Objective: To evaluate whether additional follow up brain MRI in patients with non-squamous stage III nonsmall cell lung cancer who were previously treated with curative intent radiation therapy reduces the rate of symptomatic brain metastasis presentation as compared to historical controls.

Secondary Objectives:

* To estimate time to brain failure in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
* To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.

OUTLINE:

Patients undergo MRI with or without gadolinium contrast intravenously (IV) as well as blood sample collection on study.

Patients are followed for approximately 780 days from the first treatment of radiation or until death, whichever occurs first

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age.
* Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.
* Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
* Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/- 10 days of their first treatment of radiation therapy for their locally advanced lung cancer. The first radiation treatment is defined as day 1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
* Epidermal growth factor receptor (EGFR) \> 30 mL/min/1.73m2.
* Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic resonance safety officer, and/or a radiologist as indicated in the form.

Exclusion Criteria:

* Known brain metastases on staging MRI.
* Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The recommended follow-up imaging for such findings should have no bearing on the imaging schedule in this protocol, and this research protocol imaging should NOT serve as an official follow-up scan for such findings.
* Patients who are pregnant or breastfeeding.
* Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure, they will not require a pregnancy test. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Primary outcomes:
measure: Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
timeFrame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Secondary outcomes:
measure: Time to Brain Failure
timeFrame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: Collection of Information to Document Brain Metastasis(es) - Number of Metastases
timeFrame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: Collection of Information to Document Brain Metastasis(es) - Volume of Metastases
timeFrame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: Collection of Information to Document Brain Metastasis(es) - Size of Metastases
timeFrame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Other outcomes:
measure: Frequency of Brain Metastasis(es) Directed Interventions
timeFrame: 26 months after the start of radiation therapy or until death
measure: Quality of Life - The Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
timeFrame: At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) Questionnaire
timeFrame: At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: Comparison of Exosome Measurements Between Participants
timeFrame: At baseline, 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
measure: Percentage of Brain Metastasis(es) Directed Interventions
timeFrame: 26 months after the start of radiation therapy or until death
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Michael Farris, MD
role: PRINCIPAL_INVESTIGATOR
References: