Stereotactic Radiosurgery in Treating Participants with Brain Metastases and Studying Their Neurocognitive Decline

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance score of 2 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) or magnetic resonance (MR) imaging.
  • Largest tumor =< 4 cm.
  • No prior stereotactic radiosurgery (SRS) to the lesions which will be treated on protocol.
  • Patients who have had less than or equal to 5 metastases treated with SRS are eligible.
  • 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.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, 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.
  • Patients with life expectancy < 4 months.
  • Psychiatric illness/social situations that would limit compliance with study requirements.

Locations & Contacts

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Zabi Wardak
Phone: 214-645-8525
Email: Zabi.wardak@utsouthwestern.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the toxicity within 90 days from the date of stereotactic radiosurgery (SRS), in patients with a greater intracranial disease burden, defined as 6 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 prognostic/predictive factors for local control, neurocognitive outcomes, quality of life, and toxicity based on the below exploratory objectives.

III. To determine neurocognitive outcomes via HVLT and quality of life via Functional Assessment of Cancer Therapy-Brain (FACT-Br) amongst patients treated with >= 6 metastases via SRS.

IV. To determine the overall survival (OS), defined as the time between date of SRS and date of death.

V. To determine the time to distant brain recurrence, defined as time between date of SRS and development of new metastases.

VI. To determine the incidence of salvage whole brain radiation therapy (WBRT) radiosurgery.

VII. To determine the incidence of development of leptomeningeal disease.

VIII. To prospectively collect treatment time of patients treated for multiple metastases.

EXPLORATORY OBJECTIVES:

I. 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 2.5 years.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
UT Southwestern / Simmons Cancer Center-Dallas

Principal Investigator
Zabi Wardak

Trial IDs

Primary ID SCCC-01317; STU 122016-064
Secondary IDs NCI-2018-01080
Clinicaltrials.gov ID NCT03508752