Radiation Medicine: Clinical Studies Open For Enrollment
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Eligibility
- Subject is at least 18 years of age
- Diagnosis of extensive stage small cell lung cancer
- Partial response or stable response after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab
- Must have measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST)
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04402788
Principal Investigator
Aviva Berkowitz, MD
Contact for Study Screening
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Eligibility
- Subject is at least 18 years of age
- Diagnosis of stage II or III non-small cell lung cancer (NSCLC) with known PD-L1 status
- Must have an identified primary tumor and at least one nodal metastasis
- Up to 4 cycles of systemic therapy received prior to registration is allowable; any prior chemotherapy for a different cancer is also permissible
- No evidence of distance metastases based on FDG PET/CT scan
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05624996
Principal Investigator
Aviva Berkowitz, MD
Contact for Study Screening
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Eligibility
- Subject is at least 18 years of age
- Diagnosis of unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II
- Is not optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma, or metastatic meningioma
- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT03180268
Principal Investigator
Keith Meritz, MD
Contact for Study Screening
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Eligibility
- Male at least 18 years of age
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the primary outcome are eligible for this trial
- Men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment and for 90 days after end of Radiation Therapy
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
- No prior radical prostatectomy
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05946213
Principal Investigator
Mark Hurwitz, MD
Contact for Study Screening
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Eligibility
- Male or female ≥ 18 years
- Histologically-confirmed metastatic colorectal adenocarcinoma
- No known microsatellite instable (MSI) tumor
- No known BRAF V600E mutation
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
- Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
- Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- Patients must have no overt evidence of disease progression during systemic therapy prior to registration
- Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks and a maximum of 26weeks
- For women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05946213
Principal Investigator
Mark Hurwitz, MD
Contact for Study Screening
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Eligibility
- Male ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 120 days prior to registration
- Prior curative-intent treatment to the prostate, by either:
- External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
prostate and pelvic nodes, or radiation to all three sites - Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to
the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the
pelvic nodes
- External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
- Must meet study entry criteria based on the following diagnostic workup within 180 days
prior to registration:- History and physical examination;
- Fluciclovine or PSMA PET scan (Must be positive with exception of local disease);
PET must be combined with either CT or MRI, but a diagnostic CT or MRI
reading/interpretation is not required
- 1 – 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or
PSMA PET within 180 days prior to registration and includes at least ONE of the
following:- Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
count as 2 oligometastatic lesions), - Extrapelvic Nodal/ soft tissue – requires at least one extrapelvic inguinal or a
nodal/soft tissue lesion superior to the iliac bifurcation (that is, AJCC M1a version 8).
- Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
- Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
- Serum total testosterone >100 ng/dL within 180 days prior to registration
- Exclusion Criteria:
- Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
- Currently on androgen deprivation or anti-androgen therapy
- Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
- Osseous metastasis on 99mTc radionuclide bone scan, or
- Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
- Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
- Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05053152
Principal Investigator
Mark Hurwitz, MD
Contact for Study Screening
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Eligibility
- Male or female patients must be ≥18 years of age.
- 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 - 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
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06500455
Principal Investigator
Rohil Shekher, MD
Contact for Study Screening