Clinical trial · Interventional
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Phase II Trial of Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
NCT01414738CI-TRIAL-00049607completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms, Adult, Malignant | Adult Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation
- description
- Whole-Brain Radiotherapy
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score
- timeFrame
- Baseline, 3 months
- description
- 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
Secondary outcomes (17)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.