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Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

Phase 2
18 Years
Not Enrolling
Brain Metastasis, Bladder Cancer, Breast Cancer, Cervical Cancer, Colon Cancer, HEENT Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, Prostate Cancer, Rectal Cancer, Sarcoma, Testicular Cancer

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Trial Information

Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

This is a phase II trial in patients with 1-2 brain metastases treated with surgical
resection followed by stereotactic radiosurgery boost. Following surgical resection,
patients would receive a stereotactic radiosurgery boost to the surgical bed, 2-8 weeks
after surgery. A dose of 15 to 22 Gy would be delivered in a single fraction. Patient would
be subsequently followed clinically and radiologically to watch for local control as well as
toxicity. If a recurrence or new metastasis(es) is detected, further treatment may be given,
consisting of chemotherapy, surgery, whole brain radiation therapy or stereotactic

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the local control following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Kathryn Beal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

January 2009

Related Keywords:

  • Brain Metastasis
  • Bladder Cancer
  • Breast Cancer
  • Cervical Cancer
  • Colon Cancer
  • HEENT Cancer
  • Lung Cancer
  • Melanoma
  • Pancreatic Cancer
  • Prostate Cancer
  • Rectal Cancer
  • Sarcoma
  • Testicular Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Uterine Cervical Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Testicular Neoplasms
  • Brain Neoplasms
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021