Recruiting NCT02747303
Frameless Stereotactic Radiosurgery for Intact Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Radiosurgery.
- Who it may be relevant to
- Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
Overview
This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.
Interventions
- Procedure Stereotactic Radiosurgery
The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)
Primary outcome measures
- Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months [Time frame: 6 months]
Secondary outcome measures (10)
- Progression free survival (PFS) rates estimated by the Kaplan-Meier method [Time frame: 2 years]
- Overall survival rates [Time frame: 2 years]
- Rates of radiation necrosis [Time frame: 2 years]
- Rates of pseudoprogression [Time frame: 2 years]
- Local failure rates [Time frame: 2 years]
- Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [Time frame: 90 days]
- Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [Time frame: 2 years]
- Rates of distant intracranial failure [Time frame: 2 years]
- Rates of salvage therapy [Time frame: 2 years]
- Association between dose and risk of radionecrosis or pseudoprogression [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
- Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
- Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
- Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
- Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
- Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
- Diagnosis of leptomeningeal disease.
- Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
- Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
- Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR<30, gadolinium allergy).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT02747303 · IRB15-1476