Whole Brain Radiation Using IMRT for Patients With Brain Metastases

Neoplasm Metastasis Clinical Trial

Official title: Single Center, Phase II Study of Whole Brain Radiation Using IMRT to Spare the Hippocampus While Delivering Differential Doses to Subclinical Sites Versus Gross Disease for Treatment of Patients With Brain Metastases

Status Completed

Clinical Trial Summary

Some cancers can spread, or metastasize, to the brain. When they do, treatment often involves surgery and/or radiation. Optimal treatment of brain metastases would maximize disease control and minimize toxicity (or side effects), and improve the quality of life of patients. A common type of radiation used for brain metastases is called whole brain radiation, which treats not just the cancer that can be seen on scans (i.e., gross disease), but the smaller sites of cancer that may not be visible (i.e. subclinical disease). Fractionation is used to describe repetitive treatments in which small doses (fractions) of a total planned dose are given at separate clinic visits. The most common dosing regimen is 30 Gray (Gy), using 3 Gy per fraction over 10 fractions. Previous studies have suggested that using intensity modulated radiation therapy (IMRT) may be a safer way to deliver higher doses to gross disease and lower doses to the rest of the brain that may contain subclinical disease. This approach may spare the rest of the brain from radiation complications and side effects.

The goal of this study is to determine whether using IMRT to treat brain metastases is more effective than current standard whole brain radiation in controlling gross disease and whether patient quality of life and hair loss is improved compared to previous studies using whole brain radiation.

Clinical Trial Description

This phase II clinical trial will utilize intensity modulated whole brain radiation therapy in order to deliver a smaller, yet effective dose for subclinical disease while giving a higher dose to gross disease for patients with more than one brain metastasis. In this study, a dose of 30 Gray (Gy) will be prescribed to subclinical sites and 60 or 45 Gy to visible brain metastases.

There is evidence from previous studies (including Radiation Therapy Oncology Group (RTOG) 0933) that hippocampal avoidance during whole brain radiotherapy using IMRT may decrease toxicity in the form of memory loss. Patients who had brain metastases within the region of hippocampal avoidance were not eligible for enrollment on RTOG 0933. In contrast, this study will include this group of patients since IMRT will be used to not only deliver higher doses to visible brain metastases even though they are located within the hippocampal avoidance region, but also to avoid the hippocampus itself. This approach may help to preserve memory function. Additionally, while temporary (and sometimes permanent) alopecia results from conventional whole brain radiation, IMRT spares the skin and possibly decreases the rate of hair loss. Dose to the scalp will be limited to as low as possible in order to decrease the risk of permanent alopecia in this study. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Central Nervous System Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary

• NCT number: NCT02753790
• Study type: Interventional
• Source: New Mexico Cancer Care Alliance
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Completion date: April 10, 2022