Early-Phase Safety of Proton Therapy Equipment

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Head and Neck Malignant Tumor; Malignant Glioma; Prostate Cancer
• Interventions: Radiation: proton therapy

• Registration Number: NCT02315989
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2015-11-30
• Results First Submitted QC: 2015-11-30
• Results First Posted: 2015-12-31
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
safety	proton therapy	proton therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

ChangGungMH; 🇨🇳 Taoyuan, Taiwan