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Maura Gillison MD PhD
Open to Accrual
Activation Date: December 10, 2020Most Recent Amendment Date: June 24, 2021
Head and Neck [HN]
Head and Neck
To determine the recommended phase2 dose (RP2D) of M3814 (peposertib) when given in combination with IMRT.
Pathologically (histologically) proven diagnosis of HNSCCof the oral cavity, oropharynx, larynx, or hypopharynx prior to registration; patients with oropharynx cancer need p16 determination by immunohistochemistry. Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2 -3 or T3N1-3 or T4N0-3; p16-positive oropharynx cancer patients,stages T4N0-3 or T1-3N2-3.
Data collection for this study will be done exclusively through iMedidata Rave. The Rave system can be accessed through the iMedidata portal at https://login.imedidata.com.
NRG-HN008 Co-Morbidity form is to be printed out and completed by the clinical staff on paper and uploaded in iMedidata Rave.
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