Induction chemotherapy using super selective intra-arterial cisplatin plus systemic S-1 for locally advanced oral cancer: Phase I/II study

Shuichi Imaue0 sites29 target enrollmentSeptember 20, 2022

Overview

No summary available.

Registry

who.int

Start Date

September 20, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shuichi Imaue

•1\) Histopathologically proven Squamous cell carcinoma.
•2\) Locally advanced oral cancer (T3 or T4a) with negative lymph node metastasis and distant metastasis evaluated by enhanced CT, MRI and PET/CT etc.
•3\) Desiring organ preservation therapy.
•4\) Bilateral carotid ultrasonography does not correspond to any of the following.
•.Moderate or severe stenosis in the common carotid artery or the internal carotid artery.
•.Mild stenosis of the common carotid or internal carotid arteries with unstable plaque.
•5\) 20 to 75\-year\-old at the age of registration date
•20 to 80\-year\-old at the age of registration date
•6\) Independence of activities of daily living (ECOG PS 0\-1\)
•7\) No history of treatment for oral cancer.

•1\) With active double cancer.
•2\) With an infection that requires systemic treatment.
•3\) Having a fever more than 38 degrees Celsius in axillary temperature at the time of registration.
•4\) During pregnancy or a possibility of pregnancy, within postpartum 28 days, lactating woman.
•5\) Difficult to participate in the study because of psychosis or psychiatric symptoms.
•6\) Receives continuous systemic administration of steroids or other immunosuppressive agents.
•7\) With uncontrolled diabetes.
•8\)with uncontrolled hypertension.
•9\) History of unstable angina (angina with exacerbation of onset or seizures within the last 3 weeks) or myocardial infarction within 6 months.
•10\) Positive of hepatitis B antigen.