N/A
N=56
Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
Brain Cancer · Neoplasm Metastasis · Cancer of Brain and Nervous System · Metastatic Malignant Neoplasm to Brain
Bottom Line
View on ClinicalTrials.gov: NCT00928226 ↗Enrolled (actual)
56
Serious AEs
60.7%
Results posted
Jan 2020
Primary outcome: Primary: Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD) — 0; 0; 0; 0 Dose-limited toxicity (DLT) events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fractionated Stereotactic Radiosurgery (SRS) (Radiation); Surgical resection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Local Disease Control |
4; 6; 5; 6; 0; 5 | — |
| SECONDARY Distant Intra-cranial Disease Control |
4; 3; 2; 2; 2; 3 | — |
| SECONDARY Adverse Effects Within 30 Days |
3; 4; 4; 2; 3; 4 | — |
| SECONDARY Adverse Effects More Than 30 Days up to 1 Year |
6; 1; 3; 2; 1; 3 | — |
| SECONDARY Overall Survival (OS) |
3; 4; 3; 5; 2; 5 | — |
| SECONDARY Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30 |
100; 83.3; 75; 50; 75; 87.5 | — |
| SECONDARY Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20 |
0; 16.7; 16.5; 16.7; 0; 12.5 | — |
Summary
The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined.
This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).
Eligibility Criteria
INCLUSION CRITERIA
- Age 18 years and older
- Pathologically-proven solid tumor malignancy
- 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
- Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
- Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
- Life expectancy of ≥ 12 weeks.
- Ability to understand and the willingness to sign a written informed consent.
EXCLUSION CRITERIA
- Previously treated with whole brain irradiation
- Target metastatic lesion previously been treated with SRS.
- > 4 total brain metastases at the time of initial evaluation.
- Pregnant
- Unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT00928226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.