HN Multi-ions LETd escalation study

JRCT ID: jRCTs032240451

Registered date:31/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: head and neck cancer
• Date of first enrollment: 31/10/2024
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Heavy Ion Radiotherapy

Outcome(s)

• Primary Outcome: Early adverse events

Secondary Outcome

Late adverse events
Tumor response rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Pathological proven head and neck cancer except squamous cell carcinoma of oral cavity and pharynx.
2. ECOG performance status of 0 or 1.
3. The age at the time of obtaining consent is over 18 years old.
4. Must have a life expectancy of at least 6 months.
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in this protocol.

Exclude criteria

1. Patients with extensive lymph node metastasis.
2. Patients with distant metastasis (excluding adenoid cystic carcinoma cases).
3. Those with serious complications.
4. Patients with active multiple cancers.
5. Those with a history of radiation therapy to the head and neck region.
6. The patient has an active and refractory infection.
7. Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Related Information

• Primary Sponsor: Shinoto Makoto
• Source(s) of Monetary Support: National Institutes for Quantum Science and Technology