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Completed

NCT Number: NCT05764486

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

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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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Center, Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hitachi's Heavy Ion Beam Therapy System HyBEAT

Device

treating patients with solid tumor

Primary outcomes

  1. Adverse event

    Time frame: up to 12 weeks

    The adverse reactions and the severity of all subjects in the early stage will be evaluated.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2023
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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