Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases

Completed · Phase 2

Conditions studied: Brain Neoplasms, Adult, Malignant

In brief

The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF (neurocognitive function) decline, as measured with clinical neurocognitive tools.

Key facts

Study ID

NCT01414738

Run by

University of Texas Southwestern Medical Center

People needed

50

Starts

2011-10-18

Expected to finish

2019-12-16

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy.. Direct biopsy of CNS (central nervous system) lesions is not necessarily required although could constitute an allowed site of tissue confirmation as medically prudent. Patients who have been disease free for more than 5 years prior to the appearance of CNS metastases should undergo repeat biopsy of either a systemic metastasis or the CNS metastases to confirm the recurrent malignancy.
• Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
• Patients with measurable brain metastasis who have not been or will not be treated with SRS (stereotactic radiosurgery ) or surgical resection (Note: These treatment options are only permitted at relapse)
• History/physical examination within 28 days prior to registration
• Patients must fall into RTOG (Radiation Therapy Oncology Group) recursive partitioning analysis (RPA) class I or II
• Patients must have a life expectancy of at least 4 months.
• Age ≥ 18 years
• Karnofsky performance status ≥ 70
• Patients must provide study-specific informed consent prior to study entry
• Women of childbearing potential and male participants must practice adequate contraception
• Women of childbearing potential must have a negative, qualitative serum pregnancy test ≤2 weeks prior to study entry

You may not qualify if…

• Patients with greater than 9 discrete metastases on MRI.
• Patients with leptomeningeal metastases
• Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
• Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
• Contraindication to MR (Magnetic resonance) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
• Serum creatinine > 1.4 mg/dl ≤ 28 days prior to study entry
• Prior radiation therapy to the brain
• Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to have surgical resection of ALL of their CNS lesions

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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