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

NCT01414738 | Completed Phase 2 Results DMC

• 1 other identifier: STU 042011-050
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Neoplasms, Adult, Malignant

Outcome Measures

Primary Outcomes (1)

• Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score

  The HVLT-R is a validated test to assess neurocognitive function and it incorporates 6 different forms, each including 12 nouns (targets) with 4 words drawn from 3 semantic categories. \*Delayed\*recall was measured by recalling the 12 targets after a 20-minute delay. 1 point is awarded for each successfully recalled target. There is no range- recalling more is more memory. Mean change was calculated by the following formula: 100\*(3 month - baseline) / baseline

  Baseline, 3 months

Secondary Outcomes (17)

• Mean Change in *Immediate* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R)

  Baseline, at 3 months

• Mean Change in *Delayed Recognition* Score by Hopkins Verbal Learning Test-Revised (HVLT-R)

  Baseline, 3 months

• Mean Change in Neurocognitive Function as Measured by Controlled Word Association Test

  Baseline, at 3 months

• Mean Change in Trail Making Test (TMT- A) Score

  Baseline, at 3 months

• Mean Change in Trail Making Test (TMT- B) Score

  Baseline, at 3 months

Study Arms (1)

Radiation

EXPERIMENTAL

Whole-Brain Radiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost

Radiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

SAE (Serious Adverse Events) were not analyzed on a per patient basis and hence reported as '0' within the AE module.

Results Point of Contact

• Title: Dr. Robert Timmerman
• Organization: UT Southwestern Medical Center

ROBERT.TIMMERMAN@UTSouthwestern.edu

214/645-7637

Study Officials

• Robert Timmerman, MD

  UT Southwestern Medical Center Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: October 18, 2011
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2020-03

Locations

US (1)