N/A
N=6
Early-Phase Safety of Proton Therapy Equipment
Malignant Glioma · Hepatocellular Carcinoma · Head and Neck Malignant Tumor · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02315989 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Rate and Severity of Adverse Reactions — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- proton therapy (Radiation)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate and Severity of Adverse Reactions |
6 | — |
| SECONDARY Percentage of System Errors |
12.7 | — |
| SECONDARY Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable |
50; 16.67; 33.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor
- Subjects who are measurable or with disease that is evaluable
- Subjects who are expected to survive for at least 90 days
- 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
- ECOG Performance Status (ECOG PS): 0, 1 or 2
- Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process
- Patients with well functioning main organs
- The subject retained main organ functions.
- The subject age is between 20-75 years old
Exclusion Criteria
- Subjects who once received radiotherapy on the area planned to be irradiated
- Subjects whose irradiated area has active or persistent infectious disease
- Pregnant or possibly pregnant subjects
- Subjects with other serious complications
- Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above
- The subject has the radiotherapy contraindication
- Breast feeding
- All the subjects have no plan to conception during the treatment and within one year after treatment
- 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
Data sourced from ClinicalTrials.gov (NCT02315989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.