Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

NCT03775330 | Active Not Recruiting DMC

• 1 other identifier: BRAIN METS SRS
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a parallel, prospective observational single-centre trial in patients presenting with 5 to 30 brain metastases. Patients to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT) will be enrolled.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Neurocognitive function

  Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall using the Reliable Change Index (RCI)

  2 months post treatment

Secondary Outcomes (10)

• Neurocognitive function - HVLT-R

  2 months, 4 months, 6 months, and 9 months

• Neurocognitive function - Trail Making Test

  2 months, 4 months, 6 months, and 9 months

• Neurocognitive function - Controlled Oral Word Association

  2 months, 4 months, 6 months, and 9 months

• Neurocognitive function - Clinical Trial Battery Composite

  2 months, 4 months, 6 months, and 9 months

• Local control of sites initially treated by SRS

  2 months, 4 months, 6 months, and 9 months

Study Arms (2)

SRS

Stereotactic radiosurgery

Radiation: Stereotactic Radiosurgery (SRS)

SRS plus WBRT

Stereotactic radiosurgery plus whole brain radiation

Radiation: Stereotactic Radiosurgery (SRS); Radiation: Whole brain radiation (WBRT)

Interventions

Stereotactic Radiosurgery (SRS) RADIATION

SRS or hypofractionated stereotactic radiation delivered via the Leksell Gammknife Perfexion/Icon radiosurgery system. Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions or 24-27 Gy in 3 fractions at the discretion of the radiation oncologist Maximum diameter of metastasis (doses in single fraction): ≤ 2 cm: 15-20 Gy \> 2 cm and ≤ 3 cm: 15-18 Gy \> 3 cm and ≤ 4 cm: 15 Gy Tumour location (doses in single fraction): Brainstem: 15 Gy Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions may be used for lesions \> 2 cm at the discretion of the radiation oncologist Note: SRS dosing reduced by 20% (for all prescriptions \> 15 Gy) when patient is randomized to SRS + WBRT arm

SRS; SRS plus WBRT

Whole brain radiation (WBRT) RADIATION

WBRT 20 Gy in 5 fractions or 30 Gy in 10 fractions at the discretion of the radiation oncologist

SRS plus WBRT

Eligibility Criteria

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

Study Population

The participant population will be patients who have MRI-documented 5 to 30, inclusive, brain metastases at time of enrollment and who are suitable for receiving stereotactic radiosurgery (SRS) and whole brain radiation (WBRT), with or without hippocampal-avoidance.

You may qualify if:

• Histologic or cytologic diagnosis of non-hematopoietic malignancy (excluding germ cell malignancies and small cell carcinoma).
• Patients with ≥ 5 but ≤ 30 de novo brain metastases seen on a diagnostic-quality contrast-enhanced MRI obtained within 30 days prior to enrollment (or randomization if previously randomized). Patients who are found to have 31-50 metastatic lesions at the time of treatment planning may still participate in the study. Disease progression such that \> 50 brain metastases are detected after initial MRI prior to enrollment but before SRS will be treated off-protocol as per discretion of the treating physician.
• Patients with ≥ 5 but ≤ 30 new brain metastases who have undergone prior SRS for 4 or less brain metastases with stable intracranial disease as per diagnostic MRI for at least 6 months post last course of SRS. Patients who are found to have 31-50 new metastatic lesions at the time of treatment planning may still participate in the study. Disease progression such that \> 50 new brain metastases are detected after initial MRI prior to enrollment but before SRS will be treated off-protocol as per discretion of the treating physician.
• Age ≥ 18.
• Karnofsky Performance Status (KPS) ≥ 70.
• Baseline HVLT-R above ≥ 6
• Patients must be able to tolerate WBRT, and all brain lesions must be eligible for treatment with SRS as determined by the radiation oncologist.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Patient is able to read, speak, and understand (i.e. sufficiently fluent) English in order to allow completion and meaningful analyses of the neurocognitive tests and quality of life questionnaires.
• Patients must be accessible for treatment and follow up. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• Patients who are on immunotherapy must have immunotherapy held at least 1 week before and after completion of radiotherapy. Other targeted agents/therapy must be held at least 1 day before and after SRS. Systemic chemotherapy must be held one week prior to treatment and re-started one week after treatment is complete.
• Protocol treatment is to begin within 4 weeks of patient enrollment (or randomization if previously randomized).

You may not qualify if:

• Patients with brain metastases resulting from germ cell malignancies, small cell carcinoma, or hematologic malignancies.
• Prior SRS for 5 or more brain metastases or any SRS for brain metastases within the last 6 months.
• Any prior WBRT or radiotherapy for brain metastases such that the study interventions cannot be delivered.
• Prior surgical resection of metastatic cancer from the brain.
• Patients with evidence of leptomeningeal disease.
• Patients who have a pacemaker or other contraindications, such that gadolinium-enhanced MRI cannot be performed or treatment cannot be delivered safely.
• Patients who have received chemotherapy or immunotherapy within 1 week prior to administration of protocol radiotherapy or who are expected / planned to receive chemotherapy within one week of completing protocol radiotherapy.
• Patients with \< 5 or \> 30 de novo or new brain metastases at time of enrollment, or \> 50 brain metastases at time of treatment planning.
• Patients who are pregnant (women of child-bearing age must have negative pregnancy urine test within 7 days of enrollment or randomization).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; 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

• Chia-Lin Tseng, M.D.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: December 13, 2018
• Study Start: October 20, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)