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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| safety | Other | proton therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proton therapy | Radiation | proton therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average 90 days after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Hong Hong, Ph.D. | Vice-President | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChangGungMH | Taoyuan | Taiwan | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety | proton therapy proton therapy: proton therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety | proton therapy proton therapy: proton therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Average 90 days after treatment. |
|
|
6 months (August, 2014-February, 2015)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety | proton therapy proton therapy: proton therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Case 1 On treatment: 1 Gr I "White blood cell decreased", 1 Gr II "White blood cell decreased"; Follow-up: 1 Gr I "White blood cell decreased" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hong, Ji-Hong M.D. | Linkou Chang Gung Memorial Hospital | 03-3281200 | 2600 | jihong@cgmh.org.tw |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D006528 | Carcinoma, Hepatocellular |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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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). |
| Average 100 days after treatment. |
| years |
|
| Gender | Count of Participants | Participants |
|
| 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. | Posted | Number | percentage of system errors | Average 100 days after treatment. |
|
|
|
| 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). | Posted | Number | percentage of participants | Average 100 days after treatment. |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Case 2 On treatment: 1 Gr I "Dermatitis radiation"; Case 4 On treatment: 1 Gr I & 1 Gr II "Dermatitis radiation"; Case 6 On treatment: 1 Gr I "Dermatitis radiation"; Case 7 On treatment: 2 Gr I & 1 Gr II "Dermatitis radiation"; |
|
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 3 On treatment: 1 Gr I "Anal hemorrhage", Follow-up: 1 Gr I "Anal hemorrhage", |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 3 On treatment: 1 Gr II "Rectal hemorrhage", |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Case 3 Follow-up: 1 Gr I "Anemia" |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Case 4 On treatment: 1 Gr I "Alopecia", |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 On treatment: 2 Gr I & 1 Gr II "Mucositis oral" Case 7 On treatment: 2 Gr I & 1 Gr II "Mucositis oral" |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 On treatment: 2 Gr I & 1 Gr II "Dysgeusia"; Follow-up: 1 Gr I "Dysgeusia", |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 On treatment: 2 Gr I & 1 Gr II "Dysphagia" Case 7 On treatment: 2 Gr I & 1 Gr II "Dysphagia" |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 On treatment: 1 Gr I & 1 Gr II "Dry mouth"; Follow-up: 1 Gr I "Dry mouth" Case 7 On treatment: 1 Gr I "Dry mouth"; Follow-up: 1 Gr I "Dry mouth" |
|
| Lip pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 On treatment: 1 Gr I & 1 Gr II "Lip pain", Case 7 On treatment: 2 Gr I & 1 Gr II "Lip pain" |
|
| Edema face | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 6 Follow-up: 1 Gr I "Edema face" |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Case 7 On treatment: 1 Gr I "Trismus"; Follow-up: 1 Gr I "Trismus" |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Case 7 On treatment: 1 Gr I "Constipation" |
|
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |