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Whole Brain Radiation Using IMRT for Patients With Brain Metastases

Primary Purpose

Neoplasm Metastasis, Central Nervous System Metastases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensity Modulated Radiotherapy
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Brain, Metastasis, IMRT, Radiation, Cancer, Hippocampus, Intensity modulated radiotherapy, Quality of life, QOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universtiy of New Mexico Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensity Modulated Radiotherapy (IMRT)

Arm Description

Radiation therapy to a dose of 60 Gray (Gy)/45 Gy to gross disease and 30 Gy to subclinical sites, delivered over 15 fractions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in memory
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
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.

Full Information

First Posted
April 20, 2016
Last Updated
April 21, 2022
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT02753790
Brief Title
Whole Brain Radiation Using IMRT for Patients With Brain Metastases
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
April 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Central Nervous System Metastases
Keywords
Brain, Metastasis, IMRT, Radiation, Cancer, Hippocampus, Intensity modulated radiotherapy, Quality of life, QOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensity Modulated Radiotherapy (IMRT)
Arm Type
Experimental
Arm Description
Radiation therapy to a dose of 60 Gray (Gy)/45 Gy to gross disease and 30 Gy to subclinical sites, delivered over 15 fractions
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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.
Time Frame
3 months post-treatment
Secondary Outcome Measure Information:
Title
Change in memory
Description
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.
Time Frame
4 months post-treatment
Title
Rate of permanent alopecia
Description
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.
Time Frame
12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Liem, MD
Organizational Affiliation
University of New Mexico Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.cancer.unm.edu
Description
University of New Mexico Comprehensive Cancer Center
URL
http://www.nmcca.org
Description
New Mexico Cancer Care Alliance

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Whole Brain Radiation Using IMRT for Patients With Brain Metastases

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