Malignant GliomaNCT02315989
Early-Phase Safety of Proton Therapy Equipment
A study testing proton therapy in people with Malignant Glioma and Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Malignant Glioma, Hepatocellular Carcinoma, Head and Neck Malignant Tumor
- What is being tested?
- proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patients with well functioning main organs
- The subject retained main organ functions.
- The subject age is between 20-75 years old
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Malignant Glioma, Hepatocellular Carcinoma, Head and Neck Malignant Tumor, Prostate Cancer
- Being tested
- proton therapy
- Medical subject headings
- Glioma, Carcinoma, Hepatocellular, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton therapyRadiation
proton therapy
| Study group | Role | What they receive |
|---|---|---|
| safety | Other | proton therapy Receives: Radiation: proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Average 90 days after treatment.
Secondary outcomes (2)
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.
Measured: 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).
Measured: Average 100 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji-Hong Hong, Ph.D., Principal investigator, Vice-President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315989
- Sponsor's protocol ID
- 101-5215C
- Status last verified
- Sep 2014
- First submitted
- 30 Oct 2014
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02315989
- Acronym / sponsor ID
- 101-5215C
- Conditions
- Malignant Glioma, Hepatocellular Carcinoma, Head and Neck Malignant Tumor, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Posted 31 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| safety | Other | Radiation: proton therapyproton therapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proton therapyproton therapy | Radiation | safety |
Primary outcome
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.
2 secondary outcomes
Percentage of System Errors
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
Time frame: Average 100 days after treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-Hong Hong, Ph.D. principal investigator
Vice-President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proton therapy in people with Malignant Glioma and Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Severity of Adverse Reactions (time frame: Average 90 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.