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Whole Brain Radiation Using IMRT for Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02753790
Recruitment Status : Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : September 24, 2020
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Central Nervous System Metastases Radiation: Intensity Modulated Radiotherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Intensity Modulated Radiotherapy (IMRT)
Radiation therapy to a dose of 60 Gray (Gy)/45 Gy to gross disease and 30 Gy to subclinical sites, delivered over 15 fractions
Radiation: Intensity Modulated Radiotherapy

Whole brain radiation using IMRT: 60 Gy to gross disease (planning treatment volume [PTV] 60) or 45 Gy to gross disease (PTV 45) and 30 Gy to subclinical sites (PTV 30) over 15 fractions.

Patients will be treated Monday through Friday (5 days per week) for 3 weeks. Patients with either a single metastasis greater than 15 cubic centimeters (cm) or total volume of metastases greater than 26 cubic cm will receive the lower dose of 45 Gy to visible brain metastases. 45 Gy may also be prescribed per physician discretion.

Gross disease which has received prior radiosurgery will receive 30 Gy.

Other Name: IMRT

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. Patients with metastasis of unknown primary tumor are permitted.
  • History/physical examination within 30 days prior to registration.
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Ability to understand and the willingness to sign a written informed consent document.
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Women of childbearing potential must have a negative qualitative serum pregnancy test ≤ 2 weeks prior to study entry. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 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).
  • More than one brain metastasis (qualifying measurable brain lesions are any contrast enhancing metastases identifiable by the physician).
  • Patients who have undergone a resection for brain metastases will be eligible for participation if they have any residual metastases present on post operative MRI of the brain.

Exclusion Criteria:

  • Patients with leptomeningeal metastases
  • Plan for chemotherapy or targeted therapies during whole brain radiation or within 1 week of completing radiation therapy
  • Contraindication to Magnetic Resonance (MR) imaging
  • Serum creatinine > 1.4 mg/dl ≤ 30 days prior to study entry
  • Prior radiation therapy to the brain besides radiosurgery
  • Severe active comorbidities which would make the patient an unacceptable candidate for this clinical trial per physician discretion
  • Patients with brain metastases involving the brainstem or chiasm
  • Non English speaking patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02753790

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United States, New Mexico
Universtiy of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
Sponsors and Collaborators
New Mexico Cancer Care Alliance
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Principal Investigator: Ben Liem, MD University of New Mexico Comprehensive Cancer Center
Additional Information:
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Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT02753790    
Other Study ID Numbers: INST 1409
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by New Mexico Cancer Care Alliance:
Intensity modulated radiotherapy
Quality of life
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes