Phase I/II study of induction chemotherapy using S-1 + intra-arterial cisplatin for locally advanced oral cancer

JRCT ID: jRCTs041220065

Registered date:20/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral cancer
• Date of first enrollment: 08/09/2023
• Target sample size: 29
• Study type: Interventional
• Intervention(s): Per-oral S-1 with super selective intra-arterial infusion of CDDP

Outcome(s)

Primary Outcome

Phase I: DLT develop rate
Phase II: Response rate

Secondary Outcome

Phase I: Toxicity incidence rate
Phase II: Toxicity incidence rate, severe toxicity incidence rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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
(phaseI)
20 to 80-year-old at the age of registration date
(phaseII)
6) Independence of activities of daily living (ECOG PS 0-1)
7) No history of treatment for oral cancer.
8) No history of radiation therapy to the head and neck.
9) No history of chemotherapy, including treatment for other cancer. (Excludes hormone therapy)
10) Blood test value is within a predetermined reference value range.
11) No abnormalities or abnormalities requiring treatment are found on the electrocardiogram.
12) Catheter access for the intra-arterial infusion is determined to be possible.
13) Written consent has been obtained from the patient for participation in the study.

Exclude criteria

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.

Related Information

• Primary Sponsor: Shuichi Imaue