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UMIN-CTR Clinical Trial |
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Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000021569 |
Receipt No. | R000024861 |
Official scientific title of the study | A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck |
Date of disclosure of the study information | 2016/03/24 |
Last modified on | 2018/04/13 |
Basic information | ||
Official scientific title of the study | A Phase II Study of Carbon-Ion Radiotherapy for Non-Squamous Cell Carcinoma of the Head and Neck | |
Title of the study (Brief title) | Carbon-Ion Therapy for Non-SCC of Head and Neck Tumor | |
Region |
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Condition | |||
Condition | Non-squamous cell carcinoma of 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 non-squamous cell carcinoma of head and neck, except for mucosal malignant melanoma and sarcoma |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Local control rate at 3 years |
Key secondary outcomes | 1) Overall survival, Disease-specific survival
2) Early and late adverse event rate 3) Local response rate (primary treatment outcome) |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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 |
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Key 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 |
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Target sample size | 54 |
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 Organizatio |
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 |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) | None |
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=R000024861 |