Phase 2
N=49
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Brain Neoplasms, Adult, Malignant
Bottom Line
View on ClinicalTrials.gov: NCT01414738 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score — -10.6 percentage difference
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score |
-10.6 | — |
| SECONDARY Mean Change in *Immediate* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R) |
39.6 | — |
| SECONDARY Mean Change in *Delayed Recognition* Score by Hopkins Verbal Learning Test-Revised (HVLT-R) |
-0.4 | — |
| SECONDARY Mean Change in Neurocognitive Function as Measured by Controlled Word Association Test |
3.7 | — |
| SECONDARY Mean Change in Trail Making Test (TMT- A) Score |
17.7 | — |
| SECONDARY Mean Change in Trail Making Test (TMT- B) Score |
12.0 | — |
| SECONDARY Mean Change in Cognitive Function as Measured by Medical Outcomes Scale (MOS) |
3.2 | — |
| SECONDARY Mean Change in Cognitive Function as Measured by Mini-Mental Status Examination (MMSE) |
-0.1 | — |
| SECONDARY Mean Change in Relative Fatigue as Measured by Multidimensional Fatigue Inventory (MFI-20) Scores |
6.6 | — |
| SECONDARY Cumulative Incidence of Local Failure |
8.8 | — |
| SECONDARY Cumulative Incidence of Intracranial Failure |
21.3 | — |
| SECONDARY Percentage of Participants With Local Failures Within the Region of Brain Within the CTV Receiving 20 Gy |
10.5 | — |
| SECONDARY Number of Participants With Recurrence in the Hippocampus |
1 | — |
| SECONDARY Median Progression Free Survival |
2.9 | — |
| SECONDARY Median Overall Survival. |
9 | — |
| SECONDARY Number of Adverse Events Grade 3 or Higher Based on CTCAE (Common Terminology Criteria for Adverse Events) Criteria. |
3 | — |
| SECONDARY Health-related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy With Brain Subscale (FACT-BR) |
— | — |
| SECONDARY Health-related Quality of Life as Assessed by Euroqol EQ-5D |
— | — |
Summary
The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF (neurocognitive function) decline, as measured with clinical neurocognitive tools.
Eligibility Criteria
Inclusion Criteria
- 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 (central nervous system) 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.
- Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
- Patients with measurable brain metastasis who have not been or will not be treated with SRS (stereotactic radiosurgery ) or surgical resection (Note: These treatment options are only permitted at relapse)
- History/physical examination within 28 days prior to registration
- Patients must fall into RTOG (Radiation Therapy Oncology Group) recursive partitioning analysis (RPA) class I or II
- Patients must have a life expectancy of at least 4 months.
- Age ≥ 18 years
- Karnofsky performance status ≥ 70
- Patients must provide study-specific informed consent prior to study entry
- Women of childbearing potential and male participants must practice adequate contraception
- Women of childbearing potential must have a negative, qualitative serum pregnancy test ≤2 weeks prior to study entry
Exclusion Criteria
- Patients with greater than 9 discrete metastases on MRI.
- Patients with leptomeningeal metastases
- Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
- Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
- Contraindication to MR (Magnetic resonance) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
- Serum creatinine > 1.4 mg/dl ≤ 28 days prior to study entry
- Prior radiation therapy to the brain
- Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to have surgical resection of ALL of their CNS lesions
Data sourced from ClinicalTrials.gov (NCT01414738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.