RadiotherapyNCT04579718
A Study of Radiotherapy Planning System Software ---- Zeus Cloud
An observational study of Radiotherapy, run by Sun Yat-sen University.
Trial summary
To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiotherapy
- What is being tested?
- Zeus Cloud TPS V1.0 and Eclipse
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer.
Who may be able to join
- Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer;
- The medical imaging data (CT) of the subjects were complete and available;
- Between 18 and 75 years old, regardless of gender;
Who cannot join
- The patients had metal implants;
- Not suitable for clinical trials judged by investigators.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Study on the Feasibility of a Radiotherapy Treatment Planning System (TPS) Software---Zeus Cloud
To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body.
Read the detailed description
This is a self-control, multi-center non-inferiority study. Subjects meeting inclusion criteria have radiation treatment plans designed by Zeus Cloud TPS and Eclipse treatment planning software from Varian, respectively. The qualities of two plans are compared.
This is a observational study as the two plans are not executed.
- Conditions
- Radiotherapy
- Being tested
- Zeus Cloud TPS V1.0, Eclipse
- Keywords
- Treatment Planning System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeus Cloud TPS V1.0Other
Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.
EclipseOther
Eclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Eclipse | Not described Receives: Other: Eclipse | |
| Zeus Cloud TPS V1.0 | Not described Receives: Other: Zeus Cloud TPS V1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The qualification rate of treatment plans based on dosimetry
Measured: 2 months
Secondary outcomes (3)
The conformability index of radiation dose to the target
Measured: 2 months
single-field pass rate
Measured: 2 months
composite-field pass rate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, The Affilicated Suzhou Science and Technology Town Hospital
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
- Investigators
- Hui Liu, Prof., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579718
- Sponsor's protocol ID
- GASTO-1062
- Status last verified
- Oct 2020
- First submitted
- 26 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Feasibility of a Radiotherapy Treatment Planning System (TPS) Software---Zeus Cloud
- ClinicalTrials.gov ID
- NCT04579718
- Acronym / sponsor ID
- GASTO-1062
- Conditions
- Radiotherapy
- Keywords
- Treatment Planning System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, The Affilicated Suzhou Science and Technology Town Hospital
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body.
Detailed description
This is a self-control, multi-center non-inferiority study. Subjects meeting inclusion criteria have radiation treatment plans designed by Zeus Cloud TPS and Eclipse treatment planning software from Varian, respectively. The qualities of two plans are compared.
This is a observational study as the two plans are not executed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eclipse | – | Other: Eclipse |
| Zeus Cloud TPS V1.0 | – | Other: Zeus Cloud TPS V1.0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer.
Key inclusion criteria (3 listed)
- Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer;
- The medical imaging data (CT) of the subjects were complete and available;
- Between 18 and 75 years old, regardless of gender;
Key exclusion criteria (2 listed)
- The patients had metal implants;
- Not suitable for clinical trials judged by investigators.
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 |
|---|---|---|
| Zeus Cloud TPS V1.0Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated. | Other | Zeus Cloud TPS V1.0 |
| EclipseEclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated. | Other | Eclipse |
Primary outcome
The qualification rate of treatment plans based on dosimetry
Time frame: 2 months
3 secondary outcomes
The conformability index of radiation dose to the target
Time frame: 2 months
single-field pass rate
Time frame: 2 months
composite-field pass rate
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Hui Liu, Prof. principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy, run by Sun Yat-sen University.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Qiu, MD (+86-020-87343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The qualification rate of treatment plans based on dosimetry (time frame: 2 months). 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 8 Oct 2020.