Clinical trial NCT02315989: Early-Phase Safety of Proton Therapy Equipment
Official title: A Study of the Early-Phase Safety of Proton Therapy Equipment for Patients Suffering From Solid Cancers, and the Equipment's Operational Effectiveness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Glioma
Hepatocellular Carcinoma
Head and Neck Malignant Tumor
Prostate Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate and Severity of Adverse Reactions
timeFrame: Average 90 days after treatment.
Secondary outcomes:
measure: Percentage of System Errors
timeFrame: Average 100 days after treatment.
measure: Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable
timeFrame: Average 100 days after treatment.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
Study officials:
affiliation: Vice-President
name: Ji-Hong Hong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: