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

NCT03741673 | Recruiting Phase 3 DMC

• 2 other identifiers: 2018-0552NCI-2018-02220
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm; Metastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (1)

• Leptomeningeal disease (LMD)-free rate

  Aalen-Johansen estimates will be used for LMD. Uni- and multi-variable analysis of time to LMD will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.

  At 1 year

Secondary Outcomes (3)

• Local control rate

  At 1 year

• Distant brain control

  At 1 year

• Overall survival (OS)

  At 1 year

Other Outcomes (9)

• Delta radiomics

  Up to 4 years

• Circulating tumor cell analysis

  Up to 4 years

• Cerebral spinal fluid analysis

  Up to 4 years

Study Arms (2)

Group I (pre-operative SRS)

EXPERIMENTAL

Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

Group II (post-operative SRS)

ACTIVE COMPARATOR

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (pre-operative SRS); Group II (post-operative SRS)

Questionnaire Administration OTHER

Ancillary studies

Group I (pre-operative SRS); Group II (post-operative SRS)

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Group I (pre-operative SRS); Group II (post-operative SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The primary lesion pre-operatively can have a maximum diameter of =\< 4 cm for single fraction and =\< 7 cm for multifraction therapy
• Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note
• Patients must have a Karnofsky performance scores \>= 70 or Eastern Cooperative Oncology Group (ECOG) \>= 2 within 30 days of enrollment
• Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
• No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
• Documented history of malignancy

You may not qualify if:

• Patients who have received prior radiation therapy to the brain for any reason
• The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Yeboa DN, Li J, Lin R, Prabhu SS, Beckham TH, Woodhouse K, Swanson TA, Weinberg JS, Wang X, Chi X, Ejezie CL, Suki D, Wang C, Ene C, McCutcheon IE, McGovern S, McAleer MF, Tom M, Ghia A, Perni S, Jiang W, De B, Chung C, Kim BYS, O'Brien BJ, Huse JT, Wefel JS, Court L, Tawbi H, Janku F, Guha-Thakurta N, Debnam JM, Johnson J, Taslicay CA, Alvarez-Breckenridge C, Raza SM, Heimberger AB, DeMonte F, North R, Briere TM, de Groot JF, Sawaya R, Grosshans D, Lang FF, Rao G, Ferguson SD. Therapy, Safety, and Logistics of Preoperative vs Postoperative Stereotactic Radiation Therapy: A Preliminary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2025 Aug 1;11(8):890-899. doi: 10.1001/jamaoncol.2025.1770.

  PMID: 40531511 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Debra N Yeboa

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra Yeboa

CONTACT

713-563-2300; dnyeboa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 15, 2018
• Study Start: November 8, 2018
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)