HN LET

JRCT ID: jRCTs032210020

Registered date:07/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and neck cancer
• Date of first enrollment: 26/10/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy is performed using medical heavy particle accelerator (HIMAC) installed at National Institutes for Quantum Science and Technology. The irradiation volume includes the tumor identified by medical imaging examinations. Position verification is performed by referring to bones. The irradiation is done once a day. For mucosal melanoma patient, concurrent chemotherapy is performed based on the general condition.

Outcome(s)

• Primary Outcome: Acute reactions of normal tissues
• Secondary Outcome: Preliminary local effect (non-PD rate)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Pathological proven head and neck cancer except oral and pharyngolaryngeal squamous cell carcinoma.
2. No extensive neck lymph node metastases, no distant metastases.
3. Performance status 0 to 1
4. No other life-threatening illness
5. Written informed consent

Exclude criteria

1. Severe complication
2. Active double primary
3. Prevvious irradiation at tumor site
4. Severe infection at tumor site
5. Medically, psychologically or other reason who are not suitable for candidate

Related Information

• Primary Sponsor: Koto Masashi