Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Colorectal Cancer, Skin Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Women's Studies, Pancreatic Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2004 |
| End Date: | January 2009 |
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.
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.
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.
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.
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
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