Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
This study is currently recruiting participants.
Verified January 2013 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00928226
First received: June 23, 2009
Last updated: January 16, 2013
Last verified: January 2013
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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:
|
| 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:
|
|
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:
|
|
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:
|
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
Contacts
| Contact: Leslie Modlin | (650) 723-8843 | lmodlin@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Leslie Modlin 650-723-8843 lmodlin@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: | January 16, 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 May 23, 2013