Clinical trial NCT00587964: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastasis
Bladder Cancer
Breast Cancer
Cervical Cancer
Colon Cancer
HEENT Cancer
Lung Cancer
Melanoma
Pancreatic Cancer
Prostate Cancer
Rectal Cancer
Sarcoma
Testicular Cancer
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Local Control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathryn Beal, MD
role: PRINCIPAL_INVESTIGATOR
References: