Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00928226
First received: June 23, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

To determine the optimal treatment dose for large brain metastases. Brain metastases are conventionally treated with radiation to the whole brain and/or focal radiation with stereotactic radiosurgery. With conventional radiation, control rates (i.e., the ability to completely eradicate the tumor) of large brain metastases of size greater 4 cm3 are poor. By treating these tumors over 3 treatment sessions, we hope to improve the control rate and decrease side effects for patients.


Condition Intervention Phase
Brain Cancer
Neoplasm Metastasis
Cancer of Brain and Nervous System
Metastatic Malignant Neoplasm to Brain
Procedure: Fractionated Stereotactic Radiosurgery
Device: Linear accelerator
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the local control rate as assessed on MRI and clinical exam [ Time Frame: 3, 6, 9, and 12 months following treatment ] [ Designated as safety issue: No ]
  • Determine short term and long term adverse effects [ Time Frame: 60 days (per patient) ] [ Designated as safety issue: Yes ]
  • Determine the distant intra-cranial control rate [ Time Frame: 3, 6, 9, and 12 months following treatment ] [ Designated as safety issue: No ]
  • Assess the patients health related quality of life [ Time Frame: 1, 3, 6, 9, and 12 months following treatment ] [ Designated as safety issue: No ]
  • Determine the overall survival rate [ Time Frame: Until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4.2 - 14.1 cm3 brain metastasis following surgical resection Procedure: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Device: Linear accelerator
Standard of care
Other Names:
  • linear particle accelerator
  • linac
Experimental: 14.2 - 33.5 cm3 brain metastasis following surgical resection Procedure: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Device: Linear accelerator
Standard of care
Other Names:
  • linear particle accelerator
  • linac
Experimental: 4.2 - 14.1 cm3 unresectable brain metastasis
4.2-14.1 cm3 unresectable brain metastasis treated with SRS alone
Procedure: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Device: Linear accelerator
Standard of care
Other Names:
  • linear particle accelerator
  • linac
Experimental: 14.2 - 33.5 cm3 unresectable brain metastasis
14.2 - 33.5 cm3 unresectable brain metastasis treated with SRS alone.
Procedure: Fractionated Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Device: Linear accelerator
Standard of care
Other Names:
  • linear particle accelerator
  • linac

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients age 18 years and older with pathologically proven solid tumor malignancy and 1 to 4 brain metastases, one of which is 4.2 - 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.
  • Patient must exhibit the ability to understand and the willingness to sign a written informed consent.
  • Life expectancy of at least 12 weeks.

Exclusion Criteria:

  • Patients who have previously been treated with whole brain irradiation.
  • Patients whose metastatic lesion in question had previously been treated with SRS.
  • The patient has greater than 4 total brain metastases at the time of initial evaluation.
  • Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928226

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jacob Wynne    650-723-8843    jwynne@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Scott Soltys         
Sub-Investigator: John R. Adler         
Principal Investigator: Clara Choi         
Sub-Investigator: Steven Daniel Chang         
Sub-Investigator: Iris Catrice Gibbs         
Sub-Investigator: Griffith R. Harsh         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Clara Choi Stanford University
Principal Investigator: Scott Soltys Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00928226     History of Changes
Other Study ID Numbers: BRN0010, SU-04272009-2418, 15107
Study First Received: June 23, 2009
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014