Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

NCT00928226 | Completed Results DMC FDA Device

• 3 other identifiers: IRB-15107SU-04272009-2418BRN0010
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined. This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).

Conditions

Brain Cancer; Neoplasm Metastasis; Cancer of Brain and Nervous System; Metastatic Malignant Neoplasm to Brain

Outcome Measures

Primary Outcomes (1)

• Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)

  The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as. * 5 = Death * 4 = Serious neurologic impairment such as paralysis, coma, or seizures \> 3/week * 3 = Neurologic findings requiring hospitalization * 2 = Neurologic findings present sufficient to require attendant care * 1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed * 0 = No Change The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD.

  60 days

Secondary Outcomes (7)

• Local Disease Control

  12 months

• Distant Intra-cranial Disease Control

  12 months

• Adverse Effects Within 30 Days

  30 days

• Adverse Effects More Than 30 Days up to 1 Year

  after 30 days and up to 1 year

• Overall Survival (OS)

  3 years

Study Arms (4)

Arm 1 - 24 Grey SRS

EXPERIMENTAL

24 Grey administered as 8 Gy x 3 fractions

Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection

Arm 2 - 27 Grey SRS

EXPERIMENTAL

27 Grey administered as 9 Gy x 3 fractions

Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection

Arm 3 - 30 Grey SRS

EXPERIMENTAL

30 Grey administered as 10 Gy x 3 fractions

Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection

Arm 4 - 33 Grey SRS

EXPERIMENTAL

33 Grey administered as 11 Gy x 3 fractions

Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection

Interventions

Fractionated Stereotactic Radiosurgery (SRS) RADIATION

Standard of care

Also known as: Cyberknife surgery

Arm 1 - 24 Grey SRS; Arm 2 - 27 Grey SRS; Arm 3 - 30 Grey SRS; Arm 4 - 33 Grey SRS

Surgical resection PROCEDURE

Standard of care

Arm 1 - 24 Grey SRS; Arm 2 - 27 Grey SRS; Arm 3 - 30 Grey SRS; Arm 4 - 33 Grey SRS

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• Pathologically-proven solid tumor malignancy
• to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
• Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
• Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
• Life expectancy of ≥ 12 weeks.
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Previously treated with whole brain irradiation
• Target metastatic lesion previously been treated with SRS.
• \> 4 total brain metastases at the time of initial evaluation.
• Pregnant
• Unable to give informed consent.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Rahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868.

  PMID: 34670228 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis; Neurologic Manifestations

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; Signs and Symptoms

Results Point of Contact

• Title: Scott Soltys, Associate Professor of Radiation Oncology
• Organization: Stanford University

sgsoltys@stanford.edu

65072441569

Study Officials

• Clara Choi

  Stanford University

  PRINCIPAL INVESTIGATOR

• Scott Soltys

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: April 1, 2009
• Primary Completion: October 31, 2017
• Study Completion: December 1, 2019
• Last Updated: January 30, 2024
• Results First Posted: January 22, 2020

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)