Overview

This trial is active, not recruiting.

Conditions cognitive/functional effects, metastatic cancer, unspecified adult solid tumor, protocol specific
Treatments laboratory biomarker analysis, questionnaire administration, cognitive assessment, quality-of-life assessment, intensity-modulated radiation therapy, whole-brain radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date March 2011
End date May 2013
Trial size 113 participants
Trial identifier NCT01227954, CDR0000687490, NCT01366755, RTOG-0933

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.

PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Whole Brain Radiotherapy with Hippocampal avoidance using IMRT (30 Gy in 10 fractions)
laboratory biomarker analysis
questionnaire administration
cognitive assessment
quality-of-life assessment
intensity-modulated radiation therapy
whole-brain radiation therapy

Primary Outcomes

Measure
Delayed recall at 4 months as measured by the Hopkins Verbal Learning Test-Revised
time frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT

Secondary Outcomes

Measure
Auditory and visual learning and memory as measured by the International Shopping List Test and One Card Learning Test (CogState)
time frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT
Quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) and the Barthel Index of Activities of Daily Living (ADL)
time frame: Within 2 weeks prior to treatment, 4 months after HA-WBRT
Time to radiographic progression
time frame: Baseline to date of radiographic progression
Overall survival
time frame: Baseline to date of death from any cause; patients last known to be alive are censored at date of last contact
Adverse events based on NCI CTCAE criteria
time frame: Within 2 weeks prior to treatment, 2, 4 and 12 months after HA-WBRT
ApoE4 genotype and other potentially predictive biomarkers of cognitive function
time frame: Within 2 weeks prior to treatment, 4 months

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

INCLUSION CRITERIA: - Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years - If histologic proof of malignancy is from > 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis) - Patients with metastasis of unknown primary tumor are permitted - Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days - Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection - These treatment options are allowed only at relapse - Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans - At least 1 week since open biopsy - Karnofsky performance status 70-100% - Fertile patients must use effective contraception - Negative pregnancy test 2 weeks or less prior to study entry - Patients must be English proficient, with patients who speak English as a second language eligible EXCLUSION CRITERIA: - Small cell lung cancer or germ cell malignancy - Leptomeningeal metastases - Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases - Radiologic evidence of hydrocephalus - Serum creatinine > 1.4 mg/dL within 30 days prior to study entry - Pregnant or nursing - Contraindication to MR imaging such as implanted metal devices or foreign bodies or severe claustrophobia - Severe, active co-morbidity including any of the following: - Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy - Uncontrolled, clinically significant cardiac arrhythmias - Prior radiotherapy to the brain - Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days

Additional Information

Official title A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
Principal investigator Minesh P. Mehta, MD
Description OBJECTIVES: Primary - Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in patients with brain metastasis. Secondary - Evaluate auditory and visual learning and memory, as assessed by 2 CogState tests (International Shopping List Test and One Card Learning Test), after HA-WBRT in these patients. - Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT in these patients. - Evaluate health-related quality of life [as assessed by the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of Daily Living (ADLs)] after HA-WBRT in these patients. - Evaluate time to radiographic progression after HA-WBRT in these patients. - Evaluate overall survival of these patients after HA-WBR. - Evaluate the adverse events of HA-WBR. - Evaluate predictive biomarkers of cognitive function. OUTLINE: This is a multicenter study. Patients undergo 10 fractions of intensity-modulated whole-brain radiotherapy (WBRT), avoiding hippocampal (HA) regions, once daily, 5 days a week, for 2-2½ weeks. Patients neurocognitive functions (delayed recall, auditory and visual learning, and memory) are evaluated by the Hopkins Verbal Learning Test-Revised (HVTL-R), The One Card Learning Test (OCLT), and the International Shopping List Test (ISLT) at baseline and periodically during study. Patients may undergo serum, plasma, or whole blood collection at baseline and at 4 months after completion of HA-WBRT for correlative studies. Patients may complete the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and the Barthel Index of Activities of Daily Living (ADLs) quality-of-life questionnaires at baseline and periodically during study and follow up. After completion of study therapy, patients are followed up periodically.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.