OPC-RADPLAT

JRCT ID: jRCTs011230065

Registered date:22/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Oropharyngeal Cancer
• Date of first enrollment: 22/03/2024
• Target sample size: 41
• Study type: Interventional

Intervention(s)

Radiotherapy: five times weekly, total 35 times.
Intra-arterial chemotherapy: CDDP100 mg/m2/day, once a week, maximum 6 times concurrently with radiotherapy.

Outcome(s)

Primary Outcome

(Dose-finding phase) Dose limiting toxicity rate
(Efficacy exploration phase) 2 years-local event free survival rate

Secondary Outcome

(Dose-finding phase) Adverse event incidence rate
(Efficacy exploration phase) Local event free survival period, Overall survival period, Progression free survival period, Complete clinical remission rate, Laryngeal function preservation rate, Swallowing function

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) primary lesion located at anterior or lateral wall of oropharynx
2) histologically proven squamous cell carcinoma
3) clinical stage T4aNxM0 or T4bNxM0 (p16-negative), or T4NxM0 (p16-positive)
4) no severe carotid stenosis evaluated by ultrasonography
5) ECOG performance status of 0 or 1
6) no prior therapy for oropharyngeal cancer
7) no prior radiation therapy to the head and neck
8) normal electrocardiogram
9) suitable for angiography

Exclude criteria

1) p16 immunostaining not performed
2) double cancers (except in cases where the expected life expectancy is determined to be more than 2 years after successful treatment of this oropharyngeal cancer
3) active bacterial or fungous infection
4) Women who are pregnant, possibly pregnant, within 28 days postpartum, breastfeeding, or expecting a pregnancy during the study
5) psychosis
6) requiring systemic steroids medication or immunosuppressant medication
7) poorly controlled diabetes mellitus
8) poorly controlled hypertension
9) angina pectoris attack within 3 weeks or myocardial infarction within 6 months

Related Information

• Primary Sponsor: Kanou Satoshi