Stereotactic Radiosurgery in Treating Participants with Brain Metastases and Studying Their Neurocognitive Decline
This phase I/II trial studies the best dose and side effects of stereotactic radiosurgery intreating participants whose cancer cells have spread to the brain from other organs in the body and studying their neurocognitive decline. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.
Inclusion Criteria
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better / Karnofsky performance status score of 50-60 or better.
- Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.
- Six or more metastases on diagnostic or treatment planning imaging, which include either computed tomography (CT) brain (with contrast) or magnetic resonance (MR) brain (with or without contrast) imaging.
- Largest tumor =< 4 cm.
- No prior stereotactic radiosurgery (SRS) to the lesions which will be treated on protocol.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for the duration of protocol treatment and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Prior whole brain radiotherapy.
- Patients with leptomeningeal metastasis. * NOTE: For the purposes of exclusion, leptomeningeal metastasis (LMD) is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator’s discretion based on level of clinical suspicion
- Patients with life expectancy < 4 months.
- Psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Additional locations may be listed on ClinicalTrials.gov for NCT03508752.
Locations matching your search criteria
United States
Texas
Dallas
PRIMARY OBJECTIVES:
I. To determine the toxicity within 60 days from the date of stereotactic radiosurgery (SRS), in patients with a greater intracranial disease burden, defined as six or more metastases. (Phase I)
II. Determine the cognitive deterioration (Hopkins Verbal Learning Test-Revised [HVLT-R] delayed recall) in patients treated with SRS for multiple metastases (from baseline to 4 months). (Phase II)
SECONDARY OBJECTIVES:
I. To determine the optimal dose which will provide local control in patients with a greater intracranial disease burden, defined as 6 or more metastases.
II. To determine the overall survival (OS), defined as the time between date of SRS and date of death.
EXPLORATORY OBJECTIVES:
I. To determine neurocognitive outcomes via HVLT and quality of life via Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) amongst patients treated with > 6 metastases via SRS.
II. To determine the time to distant brain recurrence, defined as time between date of SRS and development of new metastases.
III. To determine the incidence of salvage whole brain radiotherapy (WBRT) or radiosurgery.
IV. To determine the incidence of development of leptomeningeal disease.
V. Prospectively collect and analyze the following patient factors for effect on local control, neurocognitive outcomes, quality of life, and toxicity: standard patient demographics (age/performance status/gender), histology and mutational/hormone status, type of prior systemic therapy (cytotoxic, targeted, or immune therapy) controlled or uncontrolled systemic disease, neurologic symptoms at the time of SRS, number of brain metastases, size of treated brain metastases, total brain metastases volume, total treatment time, whole brain integral dose, version (V)8, V10, and V12 and relation to toxicity, hippocampal dose and relation to neurocognitive decline.
OUTLINE: This is a dose escalation study followed by a phase II study.
Participants undergo stereotactic radiosurgery over 1-5 sessions within 21 days as determined by the treating physician in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed every 2 months for 6 months, then every 3 months for up to month 24.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorZabi Wardak
- Primary IDSCCC-01317; STU 122016-064
- Secondary IDsNCI-2018-01080
- ClinicalTrials.gov IDNCT03508752