Clinical trial · Interventional
Early-Phase Safety of Proton Therapy Equipment
A Study of the Early-Phase Safety of Proton Therapy Equipment for Patients Suffering From Solid Cancers, and the Equipment's Operational Effectiveness.
NCT02315989CI-TRIAL-00025478completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Malignant Tumor | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- safety
- description
- proton therapy
- interventionNames
- Radiation: proton therapy
Primary outcomes (1)
- measure
- Rate and Severity of Adverse Reactions
- timeFrame
- Average 90 days after treatment.
- description
- After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.
Secondary outcomes (2)
- measure
- Percentage of System Errors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.