Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01227954
First received: October 22, 2010
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Cognitive/Functional Effects Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Other: laboratory biomarker analysis Other: questionnaire administration Procedure: cognitive assessment Procedure: quality-of-life assessment Radiation: intensity-modulated radiation therapy Radiation: whole-brain radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Radiation Therapy Oncology Group:
Primary Outcome Measures:
- Delayed recall at 4 months as measured by the Hopkins Verbal Learning Test-Revised [ Time Frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Auditory and visual learning and memory as measured by the International Shopping List Test and One Card Learning Test (CogState) [ Time Frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT ] [ Designated as safety issue: No ]
- Quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) and the Barthel Index of Activities of Daily Living (ADL) [ Time Frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT ] [ Designated as safety issue: No ]
- Time to radiographic progression [ Time Frame: Baseline to date of radiographic progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Baseline to date of death from any cause; patients last known to be alive are censored at date of last contact ] [ Designated as safety issue: No ]
- Adverse events based on NCI CTCAE criteria [ Time Frame: Within 2 weeks prior to treatment, 2, 4 and 12 months after HA-WBRT ] [ Designated as safety issue: Yes ]
- ApoE4 genotype and other potentially predictive biomarkers of cognitive function [ Time Frame: Within 2 weeks prior to treatment, 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HA-WBRT
Whole Brain Radiotherapy with Hippocampal avoidance using IMRT (30 Gy in 10 fractions)
|
Other: laboratory biomarker analysis Other: questionnaire administration Procedure: cognitive assessment Procedure: quality-of-life assessment Radiation: intensity-modulated radiation therapy Radiation: whole-brain radiation therapy |
Detailed Description:
OBJECTIVES:
Primary
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in patients with brain metastasis.
Secondary
- Evaluate auditory and visual learning and memory, as assessed by 2 CogState tests (International Shopping List Test and One Card Learning Test), after HA-WBRT in these patients.
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT in these patients.
- Evaluate health-related quality of life [as assessed by the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of Daily Living (ADLs)] after HA-WBRT in these patients.
- Evaluate time to radiographic progression after HA-WBRT in these patients.
- Evaluate overall survival of these patients after HA-WBR.
- Evaluate the adverse events of HA-WBR.
- Evaluate predictive biomarkers of cognitive function.
OUTLINE: This is a multicenter study.
Patients undergo 10 fractions of intensity-modulated whole-brain radiotherapy (WBRT), avoiding hippocampal (HA) regions, once daily, 5 days a week, for 2-2½ weeks.
Patients neurocognitive functions (delayed recall, auditory and visual learning, and memory) are evaluated by the Hopkins Verbal Learning Test-Revised (HVTL-R), The One Card Learning Test (OCLT), and the International Shopping List Test (ISLT) at baseline and periodically during study.
Patients may undergo serum, plasma, or whole blood collection at baseline and at 4 months after completion of HA-WBRT for correlative studies.
Patients may complete the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and the Barthel Index of Activities of Daily Living (ADLs) quality-of-life questionnaires at baseline and periodically during study and follow up.
After completion of study therapy, patients are followed up periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years
- If histologic proof of malignancy is from > 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis)
- Patients with metastasis of unknown primary tumor are permitted
- Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days
Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection
- These treatment options are allowed only at relapse
- Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans
- At least 1 week since open biopsy
- Karnofsky performance status 70-100%
- Fertile patients must use effective contraception
- Negative pregnancy test 2 weeks or less prior to study entry
- Patients must be English proficient, with patients who speak English as a second language eligible
EXCLUSION CRITERIA:
- Small cell lung cancer or germ cell malignancy
- Leptomeningeal metastases
- Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases
- Radiologic evidence of hydrocephalus
- Serum creatinine > 1.4 mg/dL within 30 days prior to study entry
- Pregnant or nursing
- Contraindication to MR imaging such as implanted metal devices or foreign bodies or severe claustrophobia
Severe, active co-morbidity including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- Uncontrolled, clinically significant cardiac arrhythmias
- Prior radiotherapy to the brain
- Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227954
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Hide Study LocationsLocations
| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Arizona Center for Cancer Care - Peoria | |
| Peoria, Arizona, United States, 85381 | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| Arizona Oncology - Tucson | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Veterans Affairs Medical Center - Long Beach | |
| Long Beach, California, United States, 90822 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Radiological Associates of Sacramento Medical Group, Incorporated | |
| Sacramento, California, United States, 95815 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| Florida Cancer Center - Palatka | |
| Palatka, Florida, United States, 32177 | |
| United States, Georgia | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| United States, Indiana | |
| Center for Cancer Care at Goshen General Hospital | |
| Goshen, Indiana, United States, 46526 | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| NSMC Cancer Center - Peabody | |
| Danvers, Massachusetts, United States, 01923 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| United States, Nebraska | |
| Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| St. Barnabas Medical Center Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| New York Oncology Hematology, PC at Albany Regional Cancer Care | |
| Albany, New York, United States, 12206 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| Southwest General Health Center | |
| Middleburg Heights, Ohio, United States, 44130 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Willamette Valley Cancer Center - Eugene | |
| Eugene, Oregon, United States, 97401 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, Pennsylvania | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Regional Cancer Center - Erie | |
| Erie, Pennsylvania, United States, 16505 | |
| Adams Cancer Center | |
| Gettysburg, Pennsylvania, United States, 17325 | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| York Cancer Center at Apple Hill Medical Center | |
| York, Pennsylvania, United States, 17405 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| Texas Oncology, PA at Harris Center HEB | |
| Bedford, Texas, United States, 76022 | |
| Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | |
| Fort Worth, Texas, United States, 76104 | |
| Memorial Hermann Hospital - Memorial City | |
| Houston, Texas, United States, 77024 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | |
| Sugar Land, Texas, United States, 77479 | |
| United States, Utah | |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Canada, Ontario | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Study Chair: | Minesh P. Mehta, MD | Ohio State University Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01227954 History of Changes |
| Obsolete Identifiers: | NCT01366755 |
| Other Study ID Numbers: | CDR0000687490, RTOG-0933 |
| Study First Received: | October 22, 2010 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Radiation Therapy Oncology Group:
|
cognitive/functional effects tumors metastatic to brain unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013