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

NCT ID: NCT01414738

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-18
• Study Completion Date: 2019-12-16

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.

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

Conditions

Brain Neoplasms, Adult, Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation

Whole-Brain Radiotherapy

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost

Interventions

Radiotherapy

Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost

Intervention Type: RADIATION

Eligibility 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 (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.

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 (stereotactic radiosurgery ) 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 (Radiation Therapy Oncology Group) 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 (Magnetic resonance) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert Timmerman

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center Dallas

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 042011-050

Identifier Type: -

Identifier Source: org_study_id