Overview

This trial is active, not recruiting.

Conditions brain cancer, neoplasm metastasis, cancer of brain and nervous system, metastatic malignant neoplasm to brain
Treatments fractionated stereotactic radiosurgery, linear accelerator
Phase phase 1/phase 2
Sponsor Stanford University
Start date April 2009
End date February 2015
Trial size 120 participants
Trial identifier NCT00928226, 15107, BRN0010, SU-04272009-2418

Summary

We hope to determine the maximum tolerated dose of 3 session (i.e., treatment) stereotactic radiosurgery to treat brain metastases greater than 4.2 cm3 in size. By increasing radiation dose, we will determine if there is a better outcome without greater toxicity (side effects) for patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
fractionated stereotactic radiosurgery Cyberknife surgery
Standard of care
linear accelerator linear particle accelerator
Standard of care
(Experimental)
fractionated stereotactic radiosurgery Cyberknife surgery
Standard of care
linear accelerator linear particle accelerator
Standard of care
(Experimental)
4.2-14.1 cm3 unresectable brain metastasis treated with SRS alone
fractionated stereotactic radiosurgery Cyberknife surgery
Standard of care
linear accelerator linear particle accelerator
Standard of care
(Experimental)
14.2 - 33.5 cm3 unresectable brain metastasis treated with SRS alone.
fractionated stereotactic radiosurgery Cyberknife surgery
Standard of care
linear accelerator linear particle accelerator
Standard of care

Primary Outcomes

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.
time frame: 60 days (per patient)

Secondary Outcomes

Measure
Determine the local control rate as assessed on MRI and clinical exam
time frame: 3, 6, 9, and 12 months following treatment
Determine short term and long term adverse effects
time frame: 60 days (per patient)
Determine the distant intra-cranial control rate
time frame: 3, 6, 9, and 12 months following treatment
Assess the patients health related quality of life
time frame: 1, 3, 6, 9, and 12 months following treatment
Determine the overall survival rate
time frame: Until death

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
Principal investigator Clara Choi
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Stanford University.