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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764486
• Other study ID #: 2021-02-013C
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Must be 20 years of age inclusive, male or female

2. Diagnosed with one of the following cancer: head and neck cancer, lung cancer, liver cancer, prostate cancer, osteosarcoma or bone and soft-tissue tumours

3. Having a lesion of less than 12cm

4. Having no metastasis at distant organ sites

5. Having a life expectancy of more than 12 weeks or longer

6. ECOG Performance Status (ECOG PS): 0, 1 or 2

7. 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

8. Able to maintain body position during irradiation

9. 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:

1. Weigh more than or equal to 135kg

2. Subjects need chemotherapy or immunotherapy as concomitant treatment

3. Have received radiotherapy on the area planned to be irradiated

4. Have received local treatment that might potentially affect endpoint evaluation, 4 weeks prior to the screening process (for instance TACE etc.)

5. Have been treated with targeted therapy, chemotherapy or immunotherapy 4 weeks prior to the screening process

6. Participated in other clinical studies within 12 weeks before screening (studies using questionnaire are exemption)

7. Subjects contraindicated in using radiotherapy

8. 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

9. Have been diagnosed with another active, uncontrolled cancer

10. Subjects whose irradiated area has active or persistent infectious disease

11. Has autoimmune diseases or connective tissue diseases

12. Subjects with other serious complications

13. Pregnant or currently breastfeeding

14. 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.

15. Subjects who are judged by the investigators as unsuitable

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Hitachi's Heavy Ion Beam Therapy System HyBEAT
treating patients with solid tumor

Locations

Country	Name	City	State
Taiwan	Cancer Center, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event	The adverse reactions and the severity of all subjects in the early stage will be evaluated.	up to 12 weeks