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A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Delayed recall at 4 months as measured by the Hopkins Verbal Learning Test-Revised

Outcome Time Frame:

Within 2 weeks prior to treatment, 4 months after HA-WBRT

Safety Issue:

No

Principal Investigator

Minesh P. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG-0933

NCT ID:

NCT01227954

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cognitive/functional effects
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Rapid City Regional HospitalRapid City, South Dakota  57709
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Rush University Medical CenterChicago, Illinois  60612-3824
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
University of California Davis Cancer CenterSacramento, California  95817
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Adena Regional Medical CenterChillicothe, Ohio  54601
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Piedmont HospitalAtlanta, Georgia  30309
OSF St. Francis Medical CenterPeoria, Illinois  61637
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Regional Cancer Center - ErieErie, Pennsylvania  16505
Florida Cancer Center - PalatkaPalatka, Florida  32177
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
NSMC Cancer Center - PeabodyPeabody, Massachusetts  01960
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
Willamette Valley Cancer Center - EugeneEugene, Oregon  97401
Texas Oncology, PA at Harris Center HEBBedford, Texas  76022
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Nebraska Medical CenterOmaha, Nebraska  68198
Arizona Oncology - TucsonTucson, Arizona  85704
Adams Cancer CenterGettysburg, Pennsylvania  17325
Memorial Hermann Hospital - Memorial CityHouston, Texas  77024