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

Phase 1

Recruiting

• Conditions: Oral cancer

• Registration Number: JPRN-jRCTs041220065
• Lead Sponsor: Shuichi Imaue

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified