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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000023182 |
Receipt No. | R000026725 |
Official scientific title of the study | A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2018/04/13 |
Basic information | ||
Official scientific title of the study | A phase II study of carbon-ion radiotherapy combined with anti-tumor agents for mucosal malignant melanoma of the head and neck | |
Title of the study (Brief title) | Carbon-ion therapy for malignant melanoma of the head and neck (iROCK-1603HN) | |
Region |
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Condition | |||
Condition | mucosal malignant melanoma of the head and neck | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of carbon-ion radiotherapy for mucosal malignant melanoma of the head and neck. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 3-year survival rate |
Key secondary outcomes | 1) Local control rate
2) Disease-specific survival 3) Early and late adverse event rate 4) Local response rate |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A total of 64.0 GyE of carbon-ion radiotherapy, consisting of 16 fractions of 4.0 GyE/ day for 6 to 8 times in 2 weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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 |
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Key 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 |
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Target sample size | 65 |
Research contact person | |
Name of lead principal investigator | Dr. Hiroyuki Katoh |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Division name | Department of Carbon-ion Radiotherapy |
Address | 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture |
TEL | 045-520-2222 |
hkatoh@kcch.jp |
Public contact | |
Name of contact person | Dr. Hiroyuki Katoh |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Division name | Ion-beam Radiation Oncology Center |
Address | 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture |
TEL | 045-520-2222 |
Homepage URL | |
hkatoh@kcch.jp |
Sponsor | |
Institute | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Institute | |
Department |
Funding Source | |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 神奈川県立がんセンター(神奈川県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026725 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |