Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
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.
Radiation: Stereotactic Radiosurgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases|
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Radiation: Stereotactic Radiosurgery
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.
Other Name: SRS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587964
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Kathryn Beal, MD||Memorial Sloan Kettering Cancer Center|