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Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Primary Purpose

Tumors Metastatic to Brain, Unspecified Adult Solid Tumor

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stereotactic radiosurgery

quality-of-life assessment

cognitive assessment

About this trial

This is an interventional treatment trial for Tumors Metastatic to Brain focused on measuring unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patient undergoing SRS for brain metastases
Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter
Patients may have had prior therapy including:
- Whole brain radiation therapy (WBRT) > 3 months ago
- SRS to other brain metastases
Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
Patient must be able to provide written informed consent

Exclusion Criteria:

Patients receiving SRS to resection bed
Planned concurrent WBRT
Leptomeningeal metastases
Small cell lung cancer, lymphoma, and germ cell histologies
Inability to participate in study activities due to physical or mental limitations
Inability or unwillingness to return for all the required follow-up visits
Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0
Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
Brainstem location is excluded from this study

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SRS)

Arm Description

Patients undergo SRS guided by CT and MRI.

Outcomes

Primary Outcome Measures

Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

Secondary Outcome Measures

Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)

Toxicity will be summarized as frequencies and percentages with a corresponding exact 95% confidence interval.

Quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) and the European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire Core 30 (QLQ30)

Full Information

NCT ID

NCT01843413

First Posted

April 26, 2013

Last Updated

October 19, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01843413

Brief Title

Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Official Title

Dose Escalation for Larger Brain Metastases: Phase I/II Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Suspended

Why Stopped

Administrative hold

Study Start Date

July 2, 2013 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II) SECONDARY OBJECTIVES: I. To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS. III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI). After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumors Metastatic to Brain, Unspecified Adult Solid Tumor

Keywords

unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Dose escalation for radiotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (SRS)

Arm Type

Experimental

Arm Description

Patients undergo SRS guided by CT and MRI.

Intervention Type

Radiation

Intervention Name(s)

stereotactic radiosurgery

Intervention Description

Undergo SRS

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

cognitive assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Time Frame

Up to 4 months

Title

Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)

Description

Toxicity will be summarized as frequencies and percentages with a corresponding exact 95% confidence interval.

Time Frame

Up to 2 years

Title

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any patient undergoing SRS for brain metastases Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter Patients may have had prior therapy including: Whole brain radiation therapy (WBRT) > 3 months ago SRS to other brain metastases Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies Patient must be able to provide written informed consent Exclusion Criteria: Patients receiving SRS to resection bed Planned concurrent WBRT Leptomeningeal metastases Small cell lung cancer, lymphoma, and germ cell histologies Inability to participate in study activities due to physical or mental limitations Inability or unwillingness to return for all the required follow-up visits Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0 Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm Brainstem location is excluded from this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Chao, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

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