Whole Brain Radiation Using IMRT for Patients With Brain Metastases

NCT02753790 | Completed DMC

• 1 other identifier: INST 1409
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Metastasis; Central Nervous System Metastases

Keywords

Brain; Metastasis; IMRT; Radiation; Cancer; Hippocampus; Intensity modulated radiotherapy; Quality of life; QOL

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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.

  3 months post-treatment

Secondary Outcomes (2)

• Change in memory

  4 months post-treatment

• Rate of permanent alopecia

  12 months post-treatment

Study Arms (1)

Intensity Modulated Radiotherapy (IMRT)

EXPERIMENTAL

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

Interventions

Intensity Modulated Radiotherapy RADIATION

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.

Also known as: IMRT

Intensity Modulated Radiotherapy (IMRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

Universtiy of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Links

• University of New Mexico Comprehensive Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Ben Liem, MD

  University of New Mexico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 28, 2016
• Study Start: March 9, 2016
• Primary Completion: April 22, 2021
• Study Completion: April 10, 2022
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)