Stereotactic Radiosurgery (SRS) for Brain Metastasis (SRS)
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|ClinicalTrials.gov Identifier: NCT02645487|
Recruitment Status : Suspended (Failed Audit; it was due to safety concerns after annual DSMC review, specifically safety assessments not being performed per protocol)
First Posted : January 1, 2016
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms, Adult, Malignant||Radiation: Stereotactic Radiosurgery||Not Applicable|
Recently, several large randomized studies have shown that in patients with limited brain metastases, whole brain radiation can be safely deferred when treated with SRS and close surveillance. In light of this, most of such patients are now treated with SRS alone without WBRT. However, the SRS doses set by Radiation Therapy Oncology Group (RTOG) 90-05 continue to be applied to patients without previous cranial irradiation.
The potential insufficiency of current SRS dose for long-term tumor control is of pressing concern. The advances chemotherapy has led to an improvement in overall survival in many patients with metastatic cancer, including malignancies often associated with brain metastases, such as lung (40-50%) and breast (15%). As these patients survive longer, more patients may develop brain metastases and the current dose of SRS may not be adequate to control the brain metastases for the duration of their survival. In fact, there is evidence that the control rate declines with time after SRS, and after 3 years, the local control rate may be only about 60%. In the case of brain metastases from relatively radio-resistant melanoma, the reported 12-months local control rates for SRS range from 52% to 75%. More potent SRS doses could lead to improved long-term control of brain metastases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study of Stereotactic Radiosurgery (SRS) for Brain Metastasis Without Whole Brain Radiation (WBRT)|
|Actual Study Start Date :||December 18, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Stereotactic Radiosurgery
Radiation, Stereotactic Radiosurgery Dose-Escalation
Radiation: Stereotactic Radiosurgery
Radiation, Stereotactic Radiosurgery Size <= 1cm: 24 Gray (Gy); + 3 Gy incremental escalation up to 30 Gy >1-2cm: 21 Gy; + 3 Gy incremental escalation up to 27 Gy >2-3cm: 18 Gy; + 3 Gy incremental escalation up to 24 Gy >3-4cm: 15 Gy; + 3 Gy incremental escalation up to 21 Gy
Other Name: SRS
- Maximal tolerated doses [ Time Frame: 90 days ]To identify the maximal tolerated doses for single-fraction stereotactic radiosurgery, within 90 days from the date of procedure, in patients with brain metastases who have not undergone prior brain irradiation.
- Overall survival [ Time Frame: 5 years ]To evaluate the overall survival (OS), which is defined as the time between date of SRS and the date of death due to any cause.
- Time to progression [ Time Frame: 5 years ]To evaluate time to progression (TTP), which is defined as the time between date of SRS and date of documented progression. Specific TTP will be determined for the target lesion, non-target lesions, and elsewhere in brain.
- Local progression rate [ Time Frame: 5 years ]To evaluate the local progression rate of the target lesion. Local progression will be defined by MRI imaging according to the modified RECIST 1.1 criteria. Suspected radiation necrosis and/or pseudoprogression will be similarly evaluate
- Response rate [ Time Frame: 5 years ]To evaluate the response rate, consisting of complete response (CR) and partial response according to the modified RECIST 1.1.
- Health-related quality of life [ Time Frame: 5 years ]To measure the improvement in health-related quality of life (HRQoL).
- chronic toxicity [ Time Frame: 90 days up to 3 years from the date of procedure ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645487
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Robert Timmerman, MD||UTSW|