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Research & Innovation

Brain Clinical Trials

Clinical Trials

Alliance N0577

Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Physician & Study Coordinator

Physician

Hugh Moulding, MD

Study Coordinator

Amy Grossman RN
484-658-1788
Amy.Grossman@sluhn.org

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Synopsis

Synopsis: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (RT + TMZ → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV) (ARM A).

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Eligibility Criteria
  • Is ≥18 years of age, at the time of signing the informed consent
  • Newly diagnosed and ≤ 3 months from surgical diagnosis, or > 3 months for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
  • Histological evidence of WHO Grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study
  • Low grade glioma must also be determined as "high risk" defined as age ≥ 40 and any surgery, ≤ 40 with prior subtotal resection or biopsy, or documented growth following prior surgery

Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p an 19q. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery.

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GTM-101

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms (NCT04427384)

Physician & Study Coordinator

Physician

Nimisha Deb, MD

Study Coordinator

Amy Grossman RN
484-658-1788
Amy.Grossman@sluhn.org

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Synopsis

Synopsis: This study will evaluate real-world clinical outcomes and patient reported outcomes that measure the effecitveness and safety of GammaTiles™ (GT).

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Eligibility Criteria
  • Patients must be scheduled to undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Patients must be able to undergo pre- and post-operative imaging for disease implant assessment
  • Patients must be fluent in either English or Spanish to allow for informed consent and completion of Quality of Life tests

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