Stereotactic Radiosurgery With Sunitinib for Brain Metastases
The purpose of this study is to determine the maximum dose of sunitinib that can be tolerated when treatment is combined with radiotherapy. Patients who decide to take part in the study will start taking sunitinib alone for 7 days. On the seventh day of taking sunitinib, patients will be given stereotactic radiosurgery (SRS).
The dose of radiation that patients will receive when they are given SRS is a standard dose used to help shrink brain metastases. The dose of radiation and the way it is delivered is not experimental.
Patients will then continue to take sunitinib seven days per week after SRS, and depending on how far along the study is when they join, they may continue taking the drug for up to 13 weeks after SRS. Patients will undergo weekly assessment during study treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Stereotactic Radiosurgery Concurrent With Sunitinib in Patients With Brain Metastases|
- Determine the safety and maximum tolerated dose of Sunitinib when combined concurrently with SRS in patients with 1-3 brain metastases [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Assess: late toxicities/Tx effect on cognitive function/potential prognostic factors/time to Intracranial Local & Distant Progression/brain Progression-free Survival/alterations in tumour perfusion parameters & effects in normal brain tissue [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Sunitinib is a tablet that is taken by mouth every day. Patients will be treated with Sunitinib alone for 7 days. On the seventh day of taking the drug they will be given SRS. Sunitinib will continue for seven days per week after SRS, and depending on how far along the study is when patients join, they may continue taking the drug for up to 13 weeks after SRS.
Brain metastases occur in 20% to 40% of all patients with cancer, with an incidence 10 times higher than that of primary malignant brain tumours. The reported median survival of patients with brain metastases is only 1-2 months with corticosteroids and 5-7 months with whole brain radiotherapy (WBRT). But with improvements in neuroimaging, brain metastases are being diagnosed more frequently and with a lower burden of disease, such that approximately 50-60% of patients have 1 to 4 brain metastases at diagnosis. In these patients, stereotactic radiosurgery (SRS), a single high dose of radiation delivered with high precision to the target lesion, is being used increasingly as an alternative to surgical resection or as an adjunct to WBRT. The addition of SRS to WBRT has provided improvements in local control and functional autonomy for patients with oligometastatic brain disease, supporting the hypothesis that SRS increases efficacy against tumours resistant to the significantly lower doses used in WBRT.
SRS can accomplish destruction of a defined intracranial target through precise targeting of a high dose of radiation with a sharp dose fall off at the target boundaries and minimal damage to surrounding tissue. Brain metastases are well suited for SRS as they are often small, radiographically well-circumscribed, pseudo-spherical tumors that are non-infiltrative, and they are often located at the gray-white junction, where toxicity to critical structures is minimal. SRS toxicity is low (<5%).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981890
|Contact: Caroline Chung, MD||416 946 4501 ext firstname.lastname@example.org|
|Contact: Cynthia Ménard, MD||416 946 4501 ext email@example.com|
|University Health Network, Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Caroline Chung, MD 416 946 4501 ext 6513 firstname.lastname@example.org|
|Contact: Cynthia Ménard, MD 416 946 4501 ext 2125 email@example.com|
|Principal Investigator:||Caroline Chung, MD||University Health Network, Princess Margaret Hospital|