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Back|NCT06500455Recruiting
Official Title

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Phase
Phase 3
Sponsor
NRG Oncology
Enrollment
269
Timeline
Dec 2024 → Jun 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
  • 2Non-small cell lung cancer
  • 3Melanoma
  • 4Breast cancer
  • 5Renal cell carcinoma
  • 6Gastrointestinal cancer
  • 7If 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
  • 8Patients 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
  • 9At 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
  • 10All 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
  • 11Note: 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
  • 12Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
  • 13No more than 2 lesions planned for resection if clinically indicated
  • 14No known leptomeningeal disease (LMD)
  • 15Note: 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
  • 16Age ≥ 18 years
  • 17Karnofsky performance status (KPS) ≥ 60
  • 18Negative 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
  • 19No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\])
  • 20New 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)
  • 21No active infection currently requiring intravenous (IV) antibiotic management
  • 22No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • 23No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

Locations

234 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Bree R. Eaton

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Bree R. Eaton

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Bree R. Eaton

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →