Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03741673
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Malignant Neoplasm
  • Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Stereotactic Radiosurgery — RADIATION
    Undergo SRS

Study Details

This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.

Key Dates

Start date
Nov 8, 2018
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (pre-operative SRS)
    Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.
  • Active Comparator: Group II (post-operative SRS)
    Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Primary Outcome Measure

Leptomeningeal disease (LMD)-free rate [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Debra N. Yeboa
713-563-2300
Debra N. Yeboa (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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