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Early-Phase Safety of Proton Therapy Equipment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02315989
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : December 31, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Hepatocellular Carcinoma Head and Neck Malignant Tumor Prostate Cancer Radiation: proton therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
safety
proton therapy
Radiation: proton therapy
proton therapy




Primary Outcome Measures :
  1. Rate and Severity of Adverse Reactions [ Time Frame: 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 :
  1. Percentage of System Errors [ Time Frame: 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.

  2. Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable [ Time Frame: 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).



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315989


Locations
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Taiwan
ChangGungMH
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ji-Hong Hong, Ph.D. Vice-President

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02315989     History of Changes
Other Study ID Numbers: 101-5215C
First Posted: December 12, 2014    Key Record Dates
Results First Posted: December 31, 2015
Last Update Posted: January 13, 2017
Last Verified: September 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Glioma
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue