Steven D. Chang, MD
Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Fractionated Stereotactic Radiosurgery
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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 Study Details
Official Title:
A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain MetastasesAnticipated start date:
4/24/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- 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 cm^3.
Secondary Outcomes:
- Determine the local control rate as assessed on MRI and clinical exam
- Determine short- and long-term adverse effects
- Determine the distant intra-cranial control rate
- Assess the patient?s health related quality of life
- Determine the overall survival rate
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
120More Information
Secondary ID(s):
- BRN0010
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/1/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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