Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors

NCT03163368 | Active Not Recruiting Early Phase 1 DMC FDA Device

• 1 other identifier: IIT2016-18-Shiao-NeoAdSRS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.

Conditions

Brain Metastases

Keywords

metastatic tumor; brain lesion; stereotactic radiosurgery; neoadjuvant; maximum tolerated dose; dose escalation; neurosurgical resection

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  To determine the maximum tolerated dose of radiosurgery given prior to neurosurgery in subjects with brain metastases of up to 4 cm.

  1 month after neurosurgery

Secondary Outcomes (7)

• Adverse events

  1 month after neurosurgery

• Describe preliminary rates of image-complete resection

  3 years

• Describe preliminary rates of local tumor control

  3 years

• Describe preliminary rates of intracranial control

  3 years

• Describe preliminary rates of progression-free survival

  3 years

Study Arms (1)

Neoadjuvant stereotactic radiosurgery

EXPERIMENTAL

Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.

Radiation: Neoadjuvant stereotactic radiosurgery; Procedure: Neurosurgical resection

Interventions

Neoadjuvant stereotactic radiosurgery RADIATION

Dose escalation of neoadjuvant stereotactic radiosurgery

Neoadjuvant stereotactic radiosurgery

Neurosurgical resection PROCEDURE

Surgical resection of newly diagnosed brain metastases

Also known as: craniotomy

Neoadjuvant stereotactic radiosurgery

Eligibility Criteria

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

You may qualify if:

• Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
• MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
• MR evidence of at least one brain lesion ≤ 40 mm in maximal diameter that is deemed to be surgically resectable as evaluated by the neurosurgeon and appropriate for SRS. All other brain lesions must be appropriate for SRS alone and treated according to physician preference. Prior neurosurgery and/or prior SRS at a non-overlapping location are permitted at the discretion of the treating physician.
• Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
• Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
• Patients aged ≥ 18 years.
• Life expectancy ≥ 3 months
• Non-acute KPS ≥ 60%

You may not qualify if:

• Patients deemed medically unfit to undergo surgical resection of brain metastasis, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions.
• Patients who have had whole brain radiation within the previous three months.
• Patients with \>4 brain metastases.
• Active or prior: documented inherited hypersensitivity syndromes, certain autoimmune diseases, and certain collagen vascular diseases. For example, any radiation hypersensitivity syndrome, including, but not limited to, ataxia-telangiectasia, Gorlin syndrome, multiple sclerosis, scleroderma, and systemic lupus erythematosus.
• Radiographic or cytologic evidence of leptomeningeal disease.
• Patients receiving methotrexate, adriamycin, epirubicine, or navelbin for one week prior to or concurrently with SRS. Note: All other systemic anti-cancer therapies will be reviewed on a case-by-case basis by study PI to determine if appropriate for study treatment and documented within the research record or EMR.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Stephen Shiao, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Basic Science Director, Radiation Oncology

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: May 9, 2017
• Primary Completion: December 15, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)