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

Condition(s) targeted: Brain Metastasis; Bladder Cancer; Breast Cancer; Cervical Cancer; Colon Cancer; HEENT Cancer; Lung Cancer; Melanoma; Pancreatic Cancer; Prostate Cancer; Rectal Cancer; Sarcoma; Testicular Cancer

Intervention: Stereotactic Radiosurgery (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Kathryn Beal, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center

Overall contact:
Kathryn Beal, MD, Email: bealk@mskcc.org

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.

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

Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: 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

Detailed description: 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 radiotherapy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Kathryn Beal, MD, Email: bealk@mskcc.org

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Kathryn Beal, MD, Email: bealk@mskcc.org

Memorial Sloan-Kettering web site

Starting date: June 2004
Ending date: June 2009
Last updated: June 17, 2008