Stereotactic Radiosurgery in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00811655
• Other study ID #: Pro00006870
• Secondary ID: P30CA014236DUMC-
• Status: Terminated
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: October 30, 2013
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Description:

OBJECTIVES:

Primary

• To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT).

Secondary

• To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone.

• To determine the volume of adjacent normal brain parenchyma irradiated in these patients.

• To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients.

• To estimate the quality of life of these patients after neoadjuvant SRS alone.

• To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients.

• To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients.

• To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients.

• To estimate the overall survival of these patients.

OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis.

Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of brain metastases from an extracranial primary site

• Tumor = 4 cm in maximal extent in any plane on contrast MRI

• Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology

• Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)

• RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:

• RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease

• RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease

• No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex

• No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)

• No radiographic or cytologic evidence of leptomeningeal disease

PATIENT CHARACTERISTICS:

• See Disease Characteristics

• Not pregnant or nursing

• Negative pregnancy test

• No concurrent uncontrolled illness including, but not limited to, any of the following:

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Psychiatric illness

• No contraindication to SRS, whole-brain radiotherapy, or MRI

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior brain surgery other than resection of metastasis

• No prior brain radiotherapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• therapeutic conventional surgery
Surgery of a single brain metastasis.

Radiation:
• stereotactic radiosurgery
Pre-operative single fraction SRS

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)	Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).	Within 12 months after SRS	No
Secondary	Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery	Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery	Within 24 months post-SRS	No
Secondary	Volume of Adjacent Normal Brain Parenchyma Irradiated	Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).	At time of SRS	No
Secondary	Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site	Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.	Within 24 months post-SRS	No
Secondary	Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)	Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.	Administered at baseline and every 3 months post-SRS	No
Secondary	Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)	Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.	Administered at baseline and every 3 months post-SRS	No
Secondary	Clinical Significance of Locally Recurrent Brain Metastases	Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.	24 months post-SRS	No
Secondary	Number of Patients Who Died Due to Neurological Causes	Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.	Within 24 months post-SRS	Yes
Secondary	Overall Survival (OS)	Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.	24 months after SRS	No