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A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck

A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck - Carbon-Ion Therapy for Non-SCC of Head and Neck Tumor

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021569
Enrollment
54
Registered
2016-03-24
Start date
2016-03-24
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

Non-squamous cell carcinoma of head and neck

Interventions

Sponsors

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A) Non-squamous cell carcinoma of head and neck which is pathologically or cytologically diagnosed, except for malignant melanoma and sarcoma B) Patient without lymph node metastasis or with clinical stage of N1 which can be treated by the same irradiation field as primary lesion C) Measurable primary lesion D) No remote metastasis E) 0 to 2 of performance status F) 15 years or older and 80 years or younger of age, and 6 months or longer of expected survival G) Patient is able to understand this clinical trial and is informed for the diagnosis and disease status. And patient can be given consent with document after explanation of this trial by study personnel

Exclusion criteria

Exclusion criteria: A) Past history of radiotherapy for the target lesion B) Less than two weeks after the last administration of chemotherapy C) Active double cancer D) Active and intractable infection in the target lesion E) Metal devices in the target lesion which is not able to be removed F) Patient is not suitable for this study due to medical, psychological or the other reason

Design outcomes

Primary

MeasureTime frame
Local control rate at 3 years

Secondary

MeasureTime frame
1) Overall survival, Disease-specific survival 2) Early and late adverse event rate 3) Local response rate (primary treatment outcome)

Countries

Japan

Contacts

Public ContactHiroyuki Katoh

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organizatio Ion-beam Radiation Oncology Center

hkatoh@kcch.jp045-520-2222

Outcome results

None listed

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