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RTOG 0933   |   CC00142
A Phase II of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases

Disease(s)
Brain
Hospital(s)
Main Campus
Phase(s)
Phase 2
Stage(s)
N/A
Type(s)
Therapeutic
Drug(s)

Contact Information
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866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description

Primary Objective

  1. Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) for brain metastasis.

Secondary Objectives

  1. 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 for brain metastasis.
  2. Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT for brain metastases.
  3. 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 for brain metastasis.
  4. Evaluate time to radiographic progression after HA-WBRT for brain metastasis.
  5. Evaluate overall survival after HA-WBRT for brain metastasis.
  6. Evaluate adverse events according to CTCAE criteria.
  7. Evaluate predictive biomarkers of cognitive function.

Inclusion Criteria
  1. Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis). Patients with metastasis of unknown primary tumor are permitted.
  2. Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration.
  3. Patients with measurable brain metastasis who have not been or will not be treated with SRS or surgical resection (Note: These treatment options are only permitted at relapse)
  4. History/physical examination within 30 days prior to registration
  5. Patients must fall into RTOG recursive partitioning analysis (RPA) class I or II (see Appendix IV)
  6. If an open biopsy is performed, the patient must be at least 1 week post-biopsy. This requirement is not necessary for stereotactic biopsies.
  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 ≤2weeks prior to study entry
  12. Patients must be English proficient, with patients who speak English as a second language eligible

Exclusion Criteria
  1. Patients with leptomeningeal metastases
  2. Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
  3. Patients with NSCLC-associated brain metastases with ≥ 2 sites of extracranial metastases
  4. Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
  5. Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
  6. Serum creatinine > 1.4 mg/dl ≤ 30 days prior to study entry
  7. Prior radiation therapy to the brain
  8. Severe, active co-morbidity, defined as follows:
    • Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • 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 at the time of registration
    • Uncontrolled, clinically significant cardiac arrhythmias
    • Radiologic evidence of hydrocephalus
  9. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.

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