Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC) - Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013706

Enrollment

145

Registered

2014-04-14

Start date

2014-04-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced maxillary sinus cancer

Interventions

A: Intra-arterial chemoradiotherapy Radiotherapy: a total dose of 70 Gy in a fraction of 2 Gy five times weekly Intra-arterial chemotherapy: CDDP100 mg/m2/day, once a week, 7 times concurrently with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) primary lesion located at maxillary sinus 2) histologically proven squamous cell carcinoma 3) clinical stage T4aN0M0 or T4bN0M0 4) no severe carotid stenosis evaluated by ultrasonography 5) age between 20 and 75 years old (dose finding phase), age between 20 and 80 years old (confirmatory phase), 6) ECOG performance status of 0 or 1 7) no prior therapy for maxillary sinus cancer 8) no prior radiation therapy to the head and neck, and the brain 9) no prior chemotherapy for any other malignancies 10) sufficient organ function 11) normal electrocardiogram 12) suitable for angiography 13) satisfy normal tissue radiation dose constraints such as at least ipsilateral eyeball and optic nerve, spinal cord, brainstem, and chiasma 14) written informed consent.

Exclusion criteria

Exclusion criteria: 1) simultaneous or metachronous (within 5 years) double cancers except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers 2) active bacterial or fungous infection 3) body temperature >= 38 degrees Celsius 4) women during pregnancy or breastfeeding 5) psychosis 6) requiring systemic steroids medication or immunosuppressant medication 7) diabetes mellitus poorly controlled 8) poorly controlled hypertension 9) angina pectoris attack within 3 weeks or myocardial infarction within 6 months 10) positive HBs antigen

Design outcomes

Primary

Measure	Time frame
3-year overall survival, The incidence of dose limiting toxicity	—

Secondary

Measure	Time frame
Overall survival, Event-free survival, Local event-free survival, Complete clinical remission rate, Adverse events, Serious adverse events	—

Countries

Japan

Contacts

Public ContactAkihiro Homma

JCOG1212 Coordinating Office Department of Otolaryngology-Head and Neck Surgery, Hokkaido University

JCOG_sir@ml.jcog.jp011-706-5958

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026