Trial Search Results

Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Radiation: intensity-modulated radiation therapy

Phase:

Phase 2

Eligibility


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 MRI 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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jacob Wynne
6507238843
Not Recruiting