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HN Multi-ions LETd escalation study

A Phase I study of dose-average LET escalation with multi-ions radiotherapy for head and neck cancers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032240451
Enrollment
18
Registered
2024-10-31
Start date
2025-12-02
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

head and neck cancer head and neck cancer

Interventions

Heavy Ion Radiotherapy
Multi-ions radiotherapy

Sponsors

Shinoto Makoto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Early adverse events

Secondary

MeasureTime frame
Late adverse events Tumor response rate

Contacts

Public ContactHiroaki Ikawa

National Institutes for Quantum Science and Technology (QST)

ikawa.hiroaki@qst.go.jp+81-43-206-3306

Outcome results

None listed

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