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A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck

A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck - Carbon-ion therapy for malignant melanoma of the head and neck (iROCK-1603HN)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023182
Enrollment
65
Registered
2016-08-01
Start date
2016-08-01
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

mucosal malignant melanoma of the head and neck

Interventions

Sponsors

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Mucosal malignant melanoma of head and neck which is pathologically or cytologically diagnosed 2) Patient without lymph node metastasis (N0) and no remote metastasis(M0) 3) Measurable primary lesion 4) 0 to 2 of performance status 5) 15 years or older and 80 years or younger of age 6)Sufficient organ functions 7) 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: 1)Patient with past history of radiotherapy for the targeted lesion 2)Patient is within 2 weeks after the final chemoterapy 3)Patient with active double cancer 4)Patients with active and intractable infection in the targeted lesion 5) Patient with metal devices in the lesion 6) Other medical or psychological condition which is unsuitable for carbon-ion therapy

Design outcomes

Primary

MeasureTime frame
3-year survival rate

Secondary

MeasureTime frame
1) Local control rate 2) Disease-specific survival 3) Early and late adverse event rate 4) Local response rate

Countries

Japan

Contacts

Public ContactHiroyuki Katoh

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

hkatoh@kcch.jp045-520-2222

Outcome results

None listed

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