A Study of Radiotherapy Planning System Software ---- Zeu... | NCT04579718

Studies
A Study of Radiotherapy Planning System Software ---- Zeus Cloud

NCT04579718

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Oct 8, 2020Actual

Enrollment

63Estimated

Phase

Not provided

Conditions

Radiotherapy

Interventions

Zeus Cloud TPS V1.0
Eclipse

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Oct 31, 2022Estimated

Completion Date

Oct 31, 2022Estimated

First Submitted Date

Sep 26, 2020

First Submission Date that Met QC Criteria

Oct 4, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2020

Last Update Posted Date

Oct 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui Liu, Professor, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
The First Affiliated Hospital of Soochow University	OTHER
The Affilicated Suzhou Science and Technology Town Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eclipse			Other: Eclipse
Zeus Cloud TPS V1.0			Other: Zeus Cloud TPS V1.0

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zeus Cloud TPS V1.0	Other	Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.	Zeus Cloud TPS V1.0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The qualification rate of treatment plans based on dosimetry		2 months

Secondary Outcomes

Measure	Description	Time Frame
The conformability index of radiation dose to the target		2 months
single-field pass rate		2 months
composite-field pass rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bo Qiu, MD	Contact	+86-020-87343031		qiubo@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Hui Liu, Prof.	Sun Yat-sen University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C509237	Eclipse Prosthodontic Resin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided