Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

NCT00814463 | Terminated Phase 2 Results

• 3 other identifiers: Pro00004373DUMC-PRO00004373CDR0000630239
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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 after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate at the Surgical Site as Measured by MRI

  The number of months for local recurrence via MRI

  12 months

Secondary Outcomes (7)

• Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery

  12 months

• Rate of New Brain Metastases Outside of the Adjuvant SRS Site

  12 months

• Quality of Life as Measured by the FACT-Br Subscales

  Every 3 months for 12 months

• Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam

  Every 3 months for 12 months.

• Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)

  12 months

Study Arms (1)

Post-operative SRS

ACTIVE COMPARATOR

All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.

Behavioral: MMSE; Behavioral: QOL via FACT-Br; Procedure: MRI; Radiation: Post-operative SRS

Interventions

MMSE BEHAVIORAL

Neurocognitive function via MMSE done every 3 months for length of study.

Also known as: Mini-Mental Status Exam

Post-operative SRS

QOL via FACT-Br BEHAVIORAL

Quality of Life via FACT-BR every 3 months for length of study.

Also known as: Quality of Life, Functional Assessment of Cancer Therapy - Brain

Post-operative SRS

MRI PROCEDURE

MRI done every 3 months for the length of the study.

Also known as: Magnetic Resonance Imagine

Post-operative SRS

Post-operative SRS RADIATION

Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.

Also known as: SRS

Post-operative SRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years of age.
• Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
• Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
• Life expectancy of at least 3 months.

You may not qualify if:

• Radiographic or cytologic evidence of leptomeningeal disease.
• Patient with incomplete or partial resection.
• Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
• Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan.
• Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
• Pregnant or need to breast feed during the study period.
• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
• Brain surgery other than for resection of metastasis.
• Previous brain radiotherapy.
• Contraindication to SRS, WBRT, or MRI.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Mental Status and Dementia Tests; Quality of Life

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Denise Lally-Goss, NP
• Organization: Duke University Medical Center

denise.lallygoss@dm.duke.edu

919-684-3862

Study Officials

• John H. Sampson, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Hamidreza Aliabadi, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• John P. Kirkpatrick, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• James E. Herndon, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 26, 2019
• Results First Posted: May 7, 2013

Record last verified: 2019-02

Locations

US (1)