Expired Study
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New York, New York 10065


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

04-061


NCT ID:

NCT00587964


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kathryn Beal, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:June 2004
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:March 2009
Last Changed Date:March 20, 2009
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary 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
Time Frame:1 year
Safety Issues:True

Study Interventions

Intervention Type:Radiation
Name:Stereotactic Radiosurgery
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 purpo
Arm Name:Treatment
Other Name:SRS

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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