Laser Interstitial Thermal Therapy or Surgery and Adjuvant Reirradiation for the Treatment of Patients with Recurrent Brain Metastases, LaSAR BeaM Trial

Status: active

This phase II trial compares the effect of laser interstitial thermal therapy (LITT) or surgery and repeat stereotactic radiosurgery (SRS) after initial course of SRS (adjuvant reirradiation [SRS2]) in treating patients with cancer that has spread to the brain from other places in the body (brain metastases) and that has come back (recurrent). There is no standard treatment model for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS). If possible, patients undergo surgery or LITT, although local recurrence rates after these interventions still occur. LITT is performed by implanting a laser catheter into the tumor and heating it to temperatures high enough to kill the tumor. A craniotomy is a surgical procedure that involves making an incision in the skull to access the brain. Surgical resection is the removal of tissue, or part or all of an organ or tumor, which can be performed during a craniotomy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Giving LITT or surgery plus adjuvant reirradiation after initial SRS may kill any remaining tumor cells in patients with recurrent brain metastases.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Willingness to comply with all study procedures and availability for the duration of the study
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study
Karnofsky performance status >= 60
Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery >= 3 months prior to study enrollment
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >= 5 mm with MRI scan
Have active tumor on pathology from surgery/LITT for this lesion
Able to safely undergo MRI imaging
Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus
Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review
Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria

Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms
Patients with psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior to SRS2 unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months) * History of hysterectomy or bilateral salpingo-oophorectomy * Ovarian failure (follicle stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy) * History of bilateral tubal ligation or another surgical sterilization procedure

PRIMARY OBJECTIVES:

I. To determine whether SRS2 following surgery/LITT for patients with recurrent previously irradiated brain metastases improves time to local recurrence compared to close surveillance following surgery/LITT.

II. To summarize time to local recurrence for patients with recurrent previously irradiated brain metastases receiving SRS2 due to being ineligible for surgery/LITT.

SECONDARY OBJECTIVES:

I. To test if the effect of SRS2 versus surveillance after LITT or surgery in patients with recurrent previously irradiated brain metastases is associated with the type of surgical intervention.

II. To determine whether SRS2 versus close surveillance following surgery/LITT for recurrent previously irradiated brain metastases improves distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival.

III. To summarize distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival for patients receiving SRS2 alone for recurrent, previously irradiated brain metastases.

IV. To summarize patient-reported outcomes including neurocognitive symptoms, functional independence, and quality of life for patients who receive SRS2 for recurrent, previously irradiated brain metastases.

V. To summarize radionecrosis and adverse event rates for patients who receive SRS2 following surgery/LITT for recurrent previously irradiated brain metastases.

EXPLORATORY OBJECTIVES:

I. To collect exploratory data on conventional, perfusion, and spectroscopic imaging studies, as well as novel treatment response assessment mapping (TRAM) with delayed contrast extravasation magnetic resonance imaging (MRI) following LITT/surgery and/or SRS2.

II. To obtain exploratory data on biospecimen correlates of local recurrence and radiation necrosis for patients receiving LITT/surgery and/or SRS2.

OUTLINE: Patients ineligible for surgery or LITT are assigned to arm 1 and patients eligible for surgery or LITT are assigned to arm 2.

ARM I: Patients undergo SRS2 over 1-5 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and blood sample collection on study.

ARM II: Patients are randomized to 1 of 2 arms.

ARM IIa: Patients undergo craniotomy and surgical resection of lesions or LITT. Patients then undergo active surveillance on study. Patients also undergo MRI and blood sample collection on study.

ARM IIb: Patients undergo craniotomy and surgical resection of lesions or LITT. Within 30 days of surgery or LITT, patients undergo SRS2 over 1-5 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and blood sample collection on study.

After completion of study treatment, patients are followed up every 3 months for 2 years after enrollment.

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Laser Interstitial Thermal Therapy or Surgery and Adjuvant Reirradiation for the Treatment of Patients with Recurrent Brain Metastases, LaSAR BeaM Trial

Inclusion Criteria

Exclusion Criteria

United States

Texas

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Laser Interstitial Thermal Therapy or Surgery and Adjuvant Reirradiation for the Treatment of Patients with Recurrent Brain Metastases, LaSAR BeaM Trial

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