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Clinical Trial 20637

Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT04114981

Phase: Phase III
Principal Investigator: Yu, Hsiang-Hsuan (Michael)

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Overview

Study Title

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

Summary

his phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction 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. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Objective

Primary objective To ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis.

Treatments

Therapies

Radiotherapy

Medications

Inclusion Criteria

PRE-REGISTRATION:

Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.

Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening.

Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.

Unresected lesions must measure > Note: The metastases size restriction does not apply to the resected brain metastasis.

One brain metastasis must be completely (gross total resection) resected => NOTE: May not have had resection of more than one brain metastasis.

The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.

Resection cavity must measure > Karnofsky performance status of >= 60.

For women of childbearing potential only, a negative urine or serum pregnancy test done => Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.

A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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 complete an MRI of the head with contrast.

The brain metastasis must be located > 5 mm of the optic chiasm and outside the brain stem.

No evidence of leptomeningeal metastasis (LMD).

Must be fluent in English, Spanish, or French.

REGISTRATION:

Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).

Exclusion Criteria

Must not have any prior whole brain radiation therapy

Past radiosurgery to other lesions is allowed

NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol).

May not have primary germ cell tumor, small cell carcinoma, or lymphoma.

o NOTE: For the purposes of exclusion, 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

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