Clinical Trial: Whole Brain Radiation Using IMRT for Patients With Brain Metastases

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: New Mexico Cancer Care Alliance

Current Primary Outcome: Overall response rate (ORR) [ Time Frame: 3 months post-treatment ]

Overall response rate (ORR) is the sum of the percentage of patients who achieve a complete response (CR) or partial response (PR). CR is defined as a total radiographic disappearance of all lesions with stabilization of the neurological examination after glucocorticoids have been stopped. PR is defined as a greater than 50% decrease in volume of all lesions as measured radiographically with improvement or stabilization of the neurological examination with stable glucocorticoid dose.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in memory [ Time Frame: 4 months post-treatment ]
    To assess change in memory, the Hopkins Verbal Learning Test-Revised (HVLT-R) will be administered prior to initiation of radiation (baseline) and at four months post-treatment. The test involves memorizing a list of 12 targets and recalling the 12 targets after a 20-minute delay (delayed recall or HVLT-R DR). Each patient will be his/her own control and the mean change in scores between baseline and four months will be calculated by subtracting the score at four months from the score at baseline and then dividing by the baseline score. A positive change indicates a decline in function. The mean change in scores will be reported.
  • Rate of permanent alopecia [ Time Frame: 12 months post-treatment ]
    Alopecia (hair loss) will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Permanent alopecia is defined as CTCAE grade 2 (moderate; >50% normal for an individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact). The percentage of patients experiencing permanent alopecia will be reported.


Original Secondary Outcome: Same as current

Information By: New Mexico Cancer Care Alliance

Dates:
Date Received: April 20, 2016
Date Started: February 2016
Date Completion: September 2022
Last Updated: June 7, 2016
Last Verified: June 2016