Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01414738
First received: August 10, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The investigators hypothesize that avoidance of the hippocampal region with WBRT may delay or reduce the onset, frequency, and/or severity of NCF decline, as measured with clinical neurocognitive tools.


Condition Intervention Phase
Brain Metastasis.
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after whole-brain radiotherapy modified as outlined (WBRT-HA/SIB) for brain metastases. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate time to neurocognitive failure as measured by cognitive decline on a battery of tests [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluate time to neurocognitive failure as measured by cognitive decline on a battery of tests: the HVLT-R for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE) after WBRT-HA/SIB for brain metastases

  • Evaluate fatigue, as assessed by the Multidimensional Fatigue Inventory (MFI-20) after WBRT-HA/SIB for brain metastases [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate local control within the brain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate local control of brain metastases treated with integrated boost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate local control within the region of brain within the CTV receiving 20 Gy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate local control within the hippocampal regions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate time to radiographic progression after WBRT-HA/SIB for brain metastasis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate overall survival after WBRT-HA/SIB for brain metastasis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate adverse events according to CTCAE criteria [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation
Whole-Brain Radiotherapy
Radiation: Radiotherapy
Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost

Detailed Description:

We propose to use conformal avoidance of the hippocampal region during whole brain radiotherapy to reduce the dose to the hippocampi, thereby putatively limiting the radiation-induced inflammation of the hippocampal region and subsequent alteration of the microenvironment of the neural progenitor cells

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy.. Direct biopsy of CNS lesions is not necessarily required although could constitute an allowed site of tissue confirmation as medically prudent. Patients who have been disease free for more than 5 years prior to the appearance of CNS metastases should undergo repeat biopsy of either a systemic metastasis or the CNS metastases to confirm the recurrent malignancy.
  2. Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
  3. Patients with measurable brain metastasis who have not been or will not be treated with SRS or surgical resection (Note: These treatment options are only permitted at relapse)
  4. History/physical examination within 28 days prior to registration
  5. Patients must fall into RTOG recursive partitioning analysis (RPA) class I or II
  6. Patients must have a life expectancy of at least 4 months.
  7. Age ≥ 18 years
  8. Karnofsky performance status ≥ 70
  9. Patients must provide study-specific informed consent prior to study entry
  10. Women of childbearing potential and male participants must practice adequate contraception
  11. Women of childbearing potential must have a negative, qualitative serum pregnancy test ≤2 weeks prior to study entry

Exclusion Criteria:

  1. Patients with greater than 9 discrete metastases on MRI.
  2. Patients with leptomeningeal metastases
  3. Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
  4. Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
  5. Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
  6. Serum creatinine > 1.4 mg/dl ≤ 28 days prior to study entry
  7. Prior radiation therapy to the brain
  8. Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to have surgical resection of ALL of their CNS lesions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414738

Contacts
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD UT Southwestern Medical Center Dallas
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01414738     History of Changes
Other Study ID Numbers: STU 042011-050
Study First Received: August 10, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014