A Study About the Operation Efficacy and the Early Stage Safety of Heavy Ion Beam Treatment System in Solid Tumor

Study Overview
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Brief Summary
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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.

Official Title
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A Study About the Operation Efficacy and the Early Stage Safety of Heavy Ion Beam Treatment System in Solid Tumor

Conditions
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Cancer

Intervention / Treatment
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* Device: Hitachi's Heavy Ion Beam Therapy System HyBEAT


Participation Criteria
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Eligibility Criteria
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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: Weigh more than or equal to 135kg Subjects need chemotherapy or immunotherapy as concomitant treatment Have received radiotherapy on the area planned to be irradiated Have received local treatment that might potentially affect endpoint evaluation, 4 weeks prior to the screening process (for instance TACE etc.) Have been treated with targeted therapy, chemotherapy or immunotherapy 4 weeks prior to the screening process Participated in other clinical studies within 12 weeks before screening (studies using questionnaire are exemption) Subjects contraindicated in using radiotherapy Wearing electronic devices, for example implantable cardiac pacemakers, implantable defibrillators, cerebrospinal stimulators, artificial hearts and cochlear implants, where the function and activity may be affected by radiation Have been diagnosed with another active, uncontrolled cancer Subjects whose irradiated area has active or persistent infectious disease Has autoimmune diseases or connective tissue diseases Subjects with other serious complications Pregnant or currently breastfeeding Planning to give birth or unable to take contraception during the screening and treatment period, as well as within 52 weeks after receiving the last treatment, regardless of gender. Subjects who are judged by the investigators as unsuitable

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: treatment plan<br>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. | Device: Hitachi's Heavy Ion Beam Therapy System HyBEAT<br>* treating patients with solid tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |