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Early-Phase Safety of Proton Therapy Equipment

Primary Purpose

Malignant Glioma, Hepatocellular Carcinoma, Head and Neck Malignant Tumor

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
proton therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ChangGungMH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

safety

Arm Description

proton therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
October 30, 2014
Last Updated
November 28, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02315989
Brief Title
Early-Phase Safety of Proton Therapy Equipment
Official Title
A Study of the Early-Phase Safety of Proton Therapy Equipment for Patients Suffering From Solid Cancers, and the Equipment's Operational Effectiveness.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Hepatocellular Carcinoma, Head and Neck Malignant Tumor, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
safety
Arm Type
Other
Arm Description
proton therapy
Intervention Type
Radiation
Intervention Name(s)
proton therapy
Intervention Description
proton therapy
Primary Outcome Measure Information:
Title
Rate and Severity of Adverse Reactions
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.
Time Frame
Average 90 days after treatment.
Secondary Outcome Measure Information:
Title
Percentage of System Errors
Description
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.
Title
Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor Subjects who are measurable or with disease that is evaluable Subjects who are expected to survive for at least 90 days 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 ECOG Performance Status (ECOG PS): 0, 1 or 2 Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process Patients with well functioning main organs The subject retained main organ functions. The subject age is between 20-75 years old Exclusion Criteria: Subjects who once received radiotherapy on the area planned to be irradiated Subjects whose irradiated area has active or persistent infectious disease Pregnant or possibly pregnant subjects Subjects with other serious complications Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above The subject has the radiotherapy contraindication Breast feeding All the subjects have no plan to conception during the treatment and within one year after treatment 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Hong Hong, Ph.D.
Organizational Affiliation
Vice-President
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChangGungMH
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Early-Phase Safety of Proton Therapy Equipment

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