Early-Phase Safety of Proton Therapy Equipment

NCT ID: NCT02315989

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-02-28

Brief Summary

The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries' proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on tumors, as well as to assess the operating functionality of the proton therapy system.

Detailed Description

The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries' proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on tumors, as well as to assess the operating functionality of the proton therapy system.

In this study, solid cancer subjects will be treated with Sumitomo's proton therapy system. Safety and operating functionality data will be collected during the treatment and following-up.

Conditions

Malignant Glioma; Hepatocellular Carcinoma; Head and Neck Malignant Tumor; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

safety

proton therapy

Group Type: OTHER

proton therapy

Intervention Type: RADIATION

proton therapy

Interventions

proton therapy

proton therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor

2. Subjects who are measurable or with disease that is evaluable

3. Subjects who are expected to survive for at least 90 days

4. Subjects who did not receive any treatment that may affect this treatment (such as PEI, TAE) 4 weeks before they are chosen to receive this treatment

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

6. Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process

7. Patients with well functioning main organs

8. The subject retained main organ functions.

9. The subject age is between 20-75 years old

Exclusion Criteria

1. Subjects who once received radiotherapy on the area planned to be irradiated

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

3. Pregnant or possibly pregnant subjects

4. Subjects with other serious complications

5. Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above

6. The subject has the radiotherapy contraindication

7. Breast feeding

8. All the subjects have no plan to conception during the treatment and within one year after treatment

9. Subject who has any electronic devices in the body which could be affected by radiotherapy and has chance to cause accident. For example: pacemaker, artificial heart, brain and spinal cord stimulation, semi-implantable and implantable electrical stimulation、artificial inner ear ...etc

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji-Hong Hong, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vice-President

Locations

ChangGungMH

Taoyuan District, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

101-5215C

Identifier Type: -

Identifier Source: org_study_id