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Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

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ClinicalTrials.gov Identifier: NCT00928226
Recruitment Status : Active, not recruiting
First Posted : June 25, 2009
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Scott Soltys, Stanford University

Brief Summary:

The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery to treat brain metastases greater than 4.2 cm3 in size will be determined.

This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).


Condition or disease Intervention/treatment Phase
Brain Cancer Neoplasm Metastasis Cancer of Brain and Nervous System Metastatic Malignant Neoplasm to Brain Radiation: Fractionated Stereotactic Radiosurgery Procedure: Surgical resection of the tumor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
Study Start Date : April 2009
Actual Primary Completion Date : October 31, 2017
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Arm 1
Participants who have brain metastasis 4.2 to 14.1 cm3 and are surgical candidates will have surgical resection of the tumor followed by fractionated stereotactic radiosurgery.
Radiation: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Procedure: Surgical resection of the tumor
Standard of care
Experimental: Arm 2
Participants who have brain metastasis 14.2 to 33.5 cm3 and are surgical candidates will have surgical resection of the tumor followed by fractionated stereotactic radiosurgery.
Radiation: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Procedure: Surgical resection of the tumor
Standard of care
Experimental: Arm 3
Participants who have brain metastasis 4.2 to 14.1 cm3 and are not surgical candidates will be treated with fractionated stereotactic radiosurgery only.
Radiation: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Experimental: Arm 4
Participants who have brain metastasis 14.2 to 33.5 cm3 and are not surgical candidates will be treated with fractionated stereotactic radiosurgery only.
Radiation: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery



Primary Outcome Measures :
  1. Determine the maximum tolerated dose (MTD) of SRS given in 3 fractions for brain metastases 4.2 - 14.1 cm3 and 14.2 - 33.5 cm3. [ Time Frame: 60 days (per patient) ]

Secondary Outcome Measures :
  1. Determine the local control rate as assessed on MRI and clinical exam [ Time Frame: 3, 6, 9, and 12 months following treatment ]
  2. Determine short term and long term adverse effects [ Time Frame: 60 days (per patient) ]
  3. Determine the distant intra-cranial control rate [ Time Frame: 3, 6, 9, and 12 months following treatment ]
  4. Assess the patients health related quality of life [ Time Frame: 1, 3, 6, 9, and 12 months following treatment ]
  5. Determine the overall survival rate [ Time Frame: Until death ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older with pathologically-proven solid tumor malignancy and 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm^3.
  • Systemic therapy: Prior cytoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytoxic systemic therapy along with SRS. Cytoxic systemic therapy to start ≥ 5 days after the completion of SRS.
  • Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
  • Ability to understand and the willingness to sign a written informed consent.
  • Life expectancy of ≥ 12 weeks.

Exclusion Criteria:

  • Previously treated with whole brain irradiation
  • Metastatic lesion in question has previously been treated with SRS.
  • > 4 total brain metastases at the time of initial evaluation.
  • Pediatric patients (age < 18), pregnant women, and those who are unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928226


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Clara Choi Stanford University
Principal Investigator: Scott Soltys Stanford University

Responsible Party: Scott Soltys, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT00928226     History of Changes
Other Study ID Numbers: IRB-15107
SU-04272009-2418 ( Other Identifier: Stanford University )
BRN0010 ( Other Identifier: OnCore )
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases