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The main purpose of this study is to investigate the safety of Hitachi's Heavy Ion Beam Therapy System HyBEAT for treating patients with solid tumor in Taipei Veterans General Hospital, including patients early-stage adverse reactions and the efficacy on tumors, as well as to assess the operation efficacy of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment plan | Other | Treatment plan performed by Hitachi's Heavy Ion Beam Therapy System HyBEAT will be designed to suit the particular needs of each subject and the course of treatment will differ for each subject depending on the type of tumor, varying from 1 day to 4 weeks. All subjects will be monitored for 12 weeks after receiving the last treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hitachi's Heavy Ion Beam Therapy System HyBEAT | Device | treating patients with solid tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | The adverse reactions and the severity of all subjects in the early stage will be evaluated. | up to 12 weeks |
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Inclusion Criteria:
Must be 20 years of age inclusive, male or female
Diagnosed with one of the following cancer: head and neck cancer, lung cancer, liver cancer, prostate cancer, osteosarcoma or bone and soft-tissue tumours
Having a lesion of less than 12cm
Having no metastasis at distant organ sites
Having a life expectancy of more than 12 weeks or longer
ECOG Performance Status (ECOG PS): 0, 1 or 2
Maintain the function of major organs and satisfy the following criteria: WBC≥3,000 / mm3 , Plt
≥75,000 / mm3 (assuming no serious bleeding tendency below 100,000), Hb≥9.5 g / dl
Able to maintain body position during irradiation
Based on his/her free will, agree to participate in the clinical study and sign and date the informed consent form after understanding the clinical study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keng-Li, Lan | Doctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Taipei Veterans General Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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