Health TrialsbyHealthPanel

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

ConditionBrain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.

Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.

Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.

Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.

Disqualifiers

Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.

Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).

Diagnosis of leptomeningeal disease.

Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Radiosurgery

    Procedure/Surgery

    The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Stereotactic Radiosurgery to 2 mm GTV to PTV marginsActive comparator 1 intervention
Group B: Stereotactic Radiosurgery to 0 mm GTV to PTV marginsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months

Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.

Time frame
6 months

Secondary outcomes

1

Progression free survival (PFS) rates estimated by the Kaplan-Meier method

Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm, and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.

Time frame
2 years
2

Overall survival rates

Time from Stereotactic Radiosurgery (SRS) completion to death.

Time frame
2 years
3

Rates of radiation necrosis

To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation necrosis.

Time frame
2 years
4

Rates of pseudoprogression

To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation pseudoprogression.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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