- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579718
A Study of Radiotherapy Planning System Software ---- Zeus Cloud
October 4, 2020 updated by: Hui Liu, Sun Yat-sen University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
63
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer.
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- The patients had metal implants;
- Not suitable for clinical trials judged by investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Eclipse
|
Eclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated.
|
Zeus Cloud TPS V1.0
|
Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The qualification rate of treatment plans based on dosimetry
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The conformability index of radiation dose to the target
Time Frame: 2 months
|
2 months
|
single-field pass rate
Time Frame: 2 months
|
2 months
|
composite-field pass rate
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Anticipated)
October 31, 2022
Study Completion (Anticipated)
October 31, 2022
Study Registration Dates
First Submitted
September 26, 2020
First Submitted That Met QC Criteria
October 4, 2020
First Posted (Actual)
October 8, 2020
Study Record Updates
Last Update Posted (Actual)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 4, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GASTO-1062
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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