Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Condition: Brain Metastasis; Bladder Cancer; Breast Cancer; Cervical Cancer; Colon Cancer; HEENT Cancer; Lung Cancer; Melanoma; Pancreatic Cancer; Prostate Cancer; Rectal Cancer; Sarcoma; Testicular Cancer
MeSH terms: Prostatic Neoplasms; Melanoma; Neoplasm Metastasis; Pancreatic Neoplasms; Sarcoma; Rectal Neoplasms; Uterine Cervical Neoplasms; Colonic Neoplasms; Urinary Bladder Neoplasms; Brain Neoplasms; Testicular Neoplasms
Intervention: Stereotactic Radiosurgery
Intervention description: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. The patient will initially receive premedication with 0.5- 1mg of Ativan orally prior to SRS procedure. Subsequently, the patient will have the stereotactic head ring placement under local anesthesia. A peripheral IV will be placed for administration of the intravenous contrast. Thin-section CT images will be obtained with intravenous contrast with head ring in place for the purpose of treatment planning.
A fusion program will be used to combine the recently obtained MRI images along with the CT scans. The target volume as well as the critical structures will be contoured. SRS would be delivered using either the Brain Lab or Radionics Radiosurgery planning and delivery system. Patients would receive a single treatment ranging from 15-22 GY.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Brain Metastasis; Radiosurgery; Bladder cancer; Breast cancer; Cervical cancer; Colon cancer; HEENT cancer; Lung cancer; Melanoma; Pancreatic cancer; Prostate cancer; Rectal cancer; Sarcoma; Testicular cancer; Radiation

Summary:

      For patients who have one or two metastases in the brain, the tumor(s) can often be removed
      with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about
      half of all patients who have the tumor(s) removed with surgery will develop regrowth
      (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation
      to the entire brain (whole brain radiation) after surgery. This involves daily treatment for
      about two to three weeks, and may cause long-term neurological problems, such as memory loss.

      Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain
      metastasis. This involves the use of a special head frame and sophisticated computer programs
      that enable us to deliver a high dose of radiation to a small focused area of the brain in
      only one treatment.

      Research has shown that the results of treatment with SRS are as good as surgical removal of
      the tumor. SRS and surgical resection are considered the standard options for the treatment
      of brain metastases. This Phase II clinical trial is studying the combination of these two
      techniques. The purpose of this study is to evaluate the use of SRS following surgical
      removal of brain metastases. The outcomes we will be looking at are tumor regrowth after
      treatment and side effects of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed malignancy with the presence of one or two intraparenchymal
             brain metastases (newly diagnosed patients may be registered based on radiologic
             confirmation if pathology is unavailable)

          -  Age ≥ 18 years

          -  Karnofsky performance status ≥ 70

          -  Neurologic Function Status 0-2

          -  Patients may have extracranial sites of metastatic disease

          -  Adequate bone marrow reserve (hemoglobin ≥ 8 grams, absolute neutrophil count ≥
             1000/mm3, platelets ≥ 50,000/mm3)

          -  Patient must sign a study specific informed consent form.

        Exclusion Criteria:

          -  Major medical illness including poor cardiac, pulmonary or renal status which would
             result in patient being a high risk candidate for neurosurgical procedure

          -  Inability to obtain histologic proof of malignancy

          -  Patients with leptomeningeal metastases documented by MRI or CSF evaluation Patients
             with metastases within 10 mm of the optic apparatus so that some portion of the optic
             nerve or chiasm would be included in the high dose SRS boost field

          -  Patients with metastases in the brainstem, midbrain, pons, or medulla

          -  Patients with small cell lung cancer, germ-cell tumors, lymphoma, leukemia and
             multiple myeloma are not eligible

          -  Younger than 18 years of age

          -  Karnofsky performance status of ≤ 60

          -  Prior history of whole brain radiation therapy

          -  Concomitant use of chemotherapy or targeted biological therapy (within a week of the
             SRS treatment)

          -  ≥ 3 metastases in the brain

          -  Allergy to both CT and MR contrast dyes

          -  Platelet count of < 100,000 or coagulation disorders that cannot be corrected or would
             render the surgery a high-risk procedure