An interventional study of proton therapy in Malignant Glioma, Hepatocellular Carcinoma and Head and Neck Malignant Tumor, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 6 is below the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
proton therapy
Radiation: proton therapy
proton therapy
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.
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.
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.
| Milestone | Safety |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| participants | Safety |
|---|---|
| Rate and Severity of Adverse Reactions | 6 |
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 system errors | The Frequency of Operation of the System Error |
|---|---|
| Percentage of System Errors | 12.7 |
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).
| percentage of participants | Stable Disease | Partial Response | Inevaluable |
|---|---|---|---|
| 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 |
Collected over 6 months (August, 2014-February, 2015). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety | — | 0/6 (0%) | 6/6 (100%) |
| Event | Safety |
|---|---|
| Dermatitis radiationSkin and subcutaneous tissue disorders | 4/6 |
| Mucositis oralGastrointestinal disorders | 2/6 |
| DysphagiaGastrointestinal disorders | 2/6 |
| Dry mouthGastrointestinal disorders | 2/6 |
| Lip painGastrointestinal disorders | 2/6 |
| White blood cell decreasedBlood and lymphatic system disorders | 1/6 |
| Anal hemorrhageGastrointestinal disorders | 1/6 |
| Rectal hemorrhageGastrointestinal disorders | 1/6 |
| AnemiaBlood and lymphatic system disorders | 1/6 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/6 |
| Age, Continuous(years) | Safety |
|---|---|
| Median | 61.5 (39 to 73) |
| Gender(Participants) | Safety |
|---|---|
| Female | 1 |
| Male | 5 |
Plan to share: No
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Chang Gung Memorial Hospital