Clinical trialPhase 2Completed
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- June 2004
- Expected end
- January 2009
- Enrollment
- 51 participants
- Sites
- 1
- Primary outcomes
- Local Control
- Sponsor
- Other
- Results posted
- 2016-02-22
- Last update
- 22 February 2016
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Local Control [1 year]. Number, participants. Local Control: Treatment - Stereotactic Radiosurgery (n=39): 13. No Evidence of Disease (NED): Treatment - Stereotactic Radiosurgery (n=39): 23. Progression of Disease (POD): Treatment - Stereotactic Radiosurgery (n=39): 2. Relapse/Recurrence: Treatment - Stereotactic Radiosurgery (n=39): 1.