Phase 2
N=51
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Brain Metastasis · Bladder Cancer · Breast Cancer · Cervical Cancer · Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00587964 ↗Enrolled (actual)
51
Serious AEs
31.4%
Results posted
Feb 2016
Primary outcome: Primary: Local Control — 13; 23; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Stereotactic Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Control |
13; 23; 2; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00587964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.