A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01

KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer.

"* Target definition for EBRT will be based on 3D imaging by computed tomography, positron emission tomography with computed tomography, or MRI.~* Intensity-modulated radiotherapy (IMRT) must be used.~* IMRT should be given once daily Monday-Friday, 5 fractions per week."

"* Weekly concomitant cisplatin (40 mg/m2) during EBRT~* Neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2) are not allowed.~* Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed."

"* BT treatment planning will be based on 3D-image-guided BT by MRI.~* Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT"