Head and Neck Malignant Tumor, Hepatocellular Carcinoma, Malignant Glioma, Prostate Cancer
Conditions
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.
Interventions
RADIATIONproton therapy
proton therapy
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and Severity of Adverse Reactions | Average 90 days after treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of System Errors | Average 100 days after treatment. | During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly. |
| Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable | Average 100 days after treatment. | Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify). |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety proton therapy
proton therapy: proton therapy | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Safety |
|---|---|
| Age, Continuous | 61.5 years |
| Gender Female | 1 Participants |
| Gender Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Rate and Severity of Adverse Reactions
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.
Time frame: Average 90 days after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety | Rate and Severity of Adverse Reactions | 6 participants |
Secondary
Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable
Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
Time frame: Average 100 days after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety | Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable | 50 percentage of participants |
| Partial Response | Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable | 16.67 percentage of participants |
| Inevaluable | Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable | 33.33 percentage of participants |
Secondary
Percentage of System Errors
During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.
Time frame: Average 100 days after treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety | Percentage of System Errors | 12.7 percentage of system errors |