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 High-risk adenocarcinoma of prostate cancer (PSA>20ng/mL or cT3a-T4 or Gleason Score 8-10 or Node positive)
- Is not metastatic disease outside of the pelvic nodes (M1a, M1b, or M1c) on imaging
- No Prior systemic chemotherapy within 3 years and No prior radiotherapy to the region of the study cancer
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04513717
Principal Investigator
Mark Hurwitz, MD
Contact for Study Screening
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Eligibility
- Subject is at least 18 years of age
- Diagnosis of intermediate-risk adenocarcinoma of prostate cancer (PSA 10-20 ng/mL or stage T2b-c or Gleason Score 7)
- No previous radical surgery (prostatectomy) or any form of curative-intent ablation for prostatic cancer
- No prior hormonal therapy and No prior radiotherapy to the prostate/pelvis region
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05050084
Principal Investigator
Mark Hurwitz, 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 or female ≥ 50 years and < 70 years of age
- The patient must have an ECOG performance status of 0 or 1
- The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins
(Patients with margins positive for LCIS are eligible without additional resection.) - The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
- Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection)
- The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
- By pathologic evaluation, primary tumor must be pT1 (≤ 2 cm)
- By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
- The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with 1% ER or PgR staining by IHC are considered positive
- Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- pT1mi and pT2–pT4 tumors including inflammatory breast cancer
- Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease
- Patient had a mastectomy
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
- Paget’s disease of the nipple
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04852887
Principal Investigator
Aviva Berkowitz, MD
Contact for Study Screening
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Eligibility
- Male or female ≥ 40 years of age
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information
- Female and Male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy
- ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60
- Histologically or cytologically confirmed invasive breast carcinoma
- Tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results
- Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0)
- Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination
- Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease
- Patient planning for or status-post mastectomy
- Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget’s disease of the nipple
- Treatment plan that includes regional nodal irradiation
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05705401
Principal Investigator
Aviva Berkowitz, 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
-
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