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

August 10, 2011
May 19, 2014
October 2011
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01414738 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Phase II Trial of Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Metastasis.
Radiation: Radiotherapy
Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost
Experimental: Radiation
Whole-Brain Radiotherapy
Intervention: Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525
United States
 
NCT01414738
STU 042011-050
Yes
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Robert Timmerman, MD UT Southwestern Medical Center Dallas
University of Texas Southwestern Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP