RecruitingPhase 3NCT06500455
Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases
Sponsor
NRG Oncology
Enrollment
269 participants
Start Date
Dec 12, 2024
Study Type
INTERVENTIONAL
Conditions
Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Renal Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Metastatic Malignant Neoplasm in the BrainMetastatic Digestive System Carcinoma
Summary
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Eligibility
Min Age: 18 Years
Inclusion Criteria23
- Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
- Non-small cell lung cancer
- Melanoma
- Breast cancer
- Renal cell carcinoma
- Gastrointestinal cancer
- If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, etc.) is required
- Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm
- All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension
- Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator
- Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\])
- New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- No active infection currently requiring intravenous (IV) antibiotic management
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
Interventions
PROCEDUREComputed Tomography
Undergo CT
RADIATIONFractionated Stereotactic Radiation Therapy
Undergo FSRS
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
RADIATIONStereotactic Radiosurgery
Undergo SRS
Locations(242)
View Full Details on ClinicalTrials.gov
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NCT06500455
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