Whole Brain Radiation Using IMRT for Patients With Brain Metastases

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02753790

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
New Mexico Cancer Care Alliance

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Ben Liem, MD
Principal Investigator Affiliation University of New Mexico Comprehensive Cancer Center

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Neoplasm Metastasis, Central Nervous System Metastases
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

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Albuquerque, New Mexico

Status

Recruiting

Address

Universtiy of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131-0001

Site Contact

Valerie Parks, RN, OCN

vparks@salud.unm.edu

505-272-0898

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