Study Design and Participants
tumor, squamous cell carcinoma of the oral cavity
ONCOLOGY, TUMOR
We conducted a randomized WOO phase II study at three centers, University Hospital “Attikon” (Athens), Hippokrateion University Hospital (Athens), and “THERMI” Clinic (Thessaloniki), in Greece. No formal comparison among the arms was performed. Patients allocated to the olaparib monotherapy arm served as a proof-of-concept to interpret the mechanism of action of olaparib. Patients allocated in the “no treatment” group were used as control. The study was initially designed as a three-arm study and was subsequently amended to include D-Olaparib arm.Newly diagnosed patients with histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that were candidates for primary surgical treatment were eligible. Additional eligibility criteria included Eastern Cooperative Oncology Group performance status ≤ 1 and sufficient biological material (tumor tissue and blood) for translational research. The trial was approved by the Institutional Review Boards of the Attikon University Hospital (Athens, Greece), Hippokrateion University Hospital (Athens, Greece), and “THERMI” Clinic (Thessaloniki, Greece) and was completed in accordance with the Protocol and Good Clinical Practice guidelines. 