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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Cancer, Neoplasm Metastasis, Cancer of Brain and Nervous System, Metastatic Malignant Neoplasm to Brain

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

60 days (per patient)

Safety Issue:

Yes

Principal Investigator

Clara Choi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRN0010

NCT ID:

NCT00928226

Start Date:

April 2009

Completion Date:

December 2016

Related Keywords:

  • Brain Cancer
  • Neoplasm Metastasis
  • Cancer of Brain and Nervous System
  • Metastatic Malignant Neoplasm to Brain
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

Stanford University School of MedicineStanford, California  94305-5317