Stereotactic Radiosurgery (SRS) Dose-Escalation Study for Brain Metastasis

Not Applicable

Recruiting

• Conditions: Brain Neoplasms, Adult, Malignant
• Interventions: Radiation: Stereotactic Radiosurgery

• Registration Number: NCT02645487
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12-18
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiosurgery	Stereotactic Radiosurgery	Radiation, Stereotactic Radiosurgery Dose-Escalation

Primary Outcome Measures

Name	Time	Method
Maximal tolerated doses	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 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.
Local progression rate	3 years	To evaluate the local progression rate of the target lesion. Local progression will be defined by MRI (with or without contrast)/CT (with contrast) imaging according to the modified RECIST 1.1 criteria. Suspected radiation necrosis and/or pseudoprogression will be similarly evaluated
Response rate	3 years	To evaluate the response rate, consisting of complete response (CR) and partial response according to the modified RECIST 1.1.
Time to progression	3 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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States