Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

Malignant Neoplasm Brain Clinical Trial

Official title:

Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514915
• Other study ID #: 14-150
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: July 22, 2021

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Description:

Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy of at least 12 weeks

• Karnofsky performance status of at least 50

• No contraindications to MRI scanning with intravenous contrast.

• MRI scan consistent with brain metastasis as per radiology report.

• Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.

• Patients must have an extra-cranial primary tumor diagnosis.

• Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.

• Additional lesions will each be treated with stereotactic radiosurgery.

• Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection

• Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

Exclusion Criteria:

• Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.

• Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.

• More than four additional diagnosed brain metastases.

• Contraindication to general anesthesia.

• Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.

• Primary brain tumor.

• Contraindication to MRI scans or intravenous contrast.

• Pregnant and breast-feeding females.

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Neoplasm Brain
• Neoplasms

Intervention

Radiation:
• Stereotactic Radiosurgery
Radiation therapy

Locations

Country	Name	City	State
United States	UPMC Shadyside Radiation Oncology Department	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Christopher Wilke

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Rate (LCR) at 6 months	Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).	At 6 months
Primary	Local Control Rate (LCR) at 12 months	Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).	At 12 months
Primary	Local Control Rate (LCR) at 24 months	Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).	At 24 months
Secondary	6-month Overall Survival (OS)	The percentage of patients alive at 6 months after the beginning of treatment.	At 6 months
Secondary	12-month Overall Survival (OS)	The percentage of patients alive at 12 months after the beginning of treatment.	At 12 months
Secondary	24-month Overall Survival (OS)	The percentage of patients alive at 24 months after the beginning of treatment.	At 24 months
Secondary	Distant Intracranial Failure	The probability of new brain metastases identified via magnetic resonance imaging.	Up to 3 years
Secondary	Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a quality of life (QOL) assessment tool used in patients with primary brain tumors. Questionnaires include the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients and the FACT-Brain (FACT-Br) which assesses brain-tumor related QOL issues. There are 50 items covering the following domains of QOL: physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale). High scores indicate better quality of life.	Up to 3 years