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

Phase 2
18 Years
Open (Enrolling)
Brain Metastasis.

Thank you

Trial Information

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

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

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

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Robert Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center Dallas


United States: Institutional Review Board

Study ID:

STU 042011-050



Start Date:

October 2011

Completion Date:

December 2016

Related Keywords:

  • Brain Metastasis.
  • Neoplasm Metastasis
  • Brain Neoplasms



University of Texas Southwestern Medical CenterDallas, Texas