Status:
COMPLETED
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Brain Neoplasms, Adult, Malignant
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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) ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01414738
Start Date
October 18 2011
End Date
December 16 2019
Last Update
January 26 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390