NCT04427228

Brief Summary

This study is meant to compare different surgical approaches to brain cancer.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

June 8, 2020

Last Update Submit

August 24, 2023

Conditions

Brain CancerBrain Metastases

Outcome Measures

Primary Outcomes (1)

  • Multi-Fraction SRS superiority compared to single fraction SRS

    To determine if Multi-Fraction SRS will decrease the rate of radionecrosis when compared to single-fraction SRS for patients with small metastases and are on immunotherapy.

    4 years

Secondary Outcomes (9)

  • Target metastasis progression

    4 years

  • Overall Survival Rate

    4 years

  • Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities

    4 years

  • Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities

    4 years

  • rate of individual metastases radionecrosis

    4 years

  • +4 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL
Radiation: Radiosurgery Three Treatments

ARM B

ACTIVE COMPARATOR
Radiation: Radiosurgery Single Treatment

Interventions

Radiosurgery Single TreatmentRADIATION

Frameless single-fraction SRS. One large treatment done on each brain tumor. 20 Gy for GTVs (or resection cavity CTVs) \< 2 cm, and 18 Gy for GTVs (or resection cavity CTVs) between 2-3 cm in the single-fraction.

Also known as: SRS
ARM B
Radiosurgery Three TreatmentsRADIATION

Multi-fraction SRS. Three small doses done on each brain tumor. 27 Gy in 3 fractions in the multi-fraction group

Also known as: SRS
Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i. Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
  • ii. Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain metastases.
  • iii. Well-circumscribed, measureable intraparenchymal brain metastasis(s) with maximum tumor diameter ≤3.0 cm. If multiple metastases are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one metastasis must be ≥ 0.5 cm in maximum diameter to be considered measurable disease.
  • iv. Negative urine or serum pregnancy test done ≤ 21 days prior to CT simulation, for women of child bearing potential only.
  • v. Ability to understand and willingness to sign a written informed consent document.
  • vi. Must have received immunotherapy (PD-1/PD-L1 and/or CTLA-4 inhibitor(s)) within the past 6 months or plan on receiving immunotherapy within the next 1 month.
  • vii. Must have a Gustave Roussy Immune Score (GRIm-Score) of 0 or 1 (neutrophil-to-lymphocyte ratio \> 6 = 1 point, LDH \> Upper Limit of Normal = 1 point, and Albumin \< 3.5 g/dL = 1 point).

You may not qualify if:

  • i. Diagnosis of germ cell tumor or hematologic malignancy. ii. Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
  • iii. Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately adjacent lesion(s) of interest or to the current lesion(s) of interest.
  • v. Prior history of pseudoprogression or radionecrosis from cranial radiotherapy.
  • vi. A neurosurgical resection cavity deemed too large by the radiation oncologist to be treated with a single fraction of stereotactic radiosurgery.
  • vii. Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR \<30, gadolinium allergy).
  • viii. A Gustave Roussy Immune Score (GRIm-Score) \> 1 (neutrophil-to-lymphocyte ratio \> 6 = 1 point, LDH \> Upper Limit of Normal = 1 point, and Albumin \< 3.5 g/dL = 1 point).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Steven Chmura, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

June 29, 2020

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

US(1)