Stereotactic Radiosurgery in Treating Patients With Brain Metastases

NCT00811655 | Terminated Phase 2 Results

• 4 other identifiers: Pro00006870P30CA014236DUMC-PRO00006870CDR0000630230
• Study Type: interventional
• Target: 6
• 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 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.

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)

• 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

Secondary Outcomes (8)

• Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery

  Within 24 months post-SRS

• Volume of Adjacent Normal Brain Parenchyma Irradiated

  At time of SRS

• Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site

  Within 24 months post-SRS

• Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)

  Administered at baseline and every 3 months post-SRS

• Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)

  Administered at baseline and every 3 months post-SRS

Study Arms (1)

Pre-Operative SRS

EXPERIMENTAL

SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.

Procedure: therapeutic conventional surgery; Radiation: stereotactic radiosurgery

Interventions

therapeutic conventional surgery PROCEDURE

Surgery of a single brain metastasis.

Pre-Operative SRS

stereotactic radiosurgery RADIATION

Pre-operative single fraction SRS

Pre-Operative SRS

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Radiosurgery

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

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 18, 2008
• First Posted: December 19, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-10

Locations

US (1)