Effect of FDG-PET/CT for Simulation and Radiation Treatme... | NCT03008694

Studies
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients

NCT03008694

Sponsor

Zhongnan Hospital

Status

Unknown status

Last Update Posted

Jan 2, 2017Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Oral Cancer
Radiotherapy; Complications

Interventions

PET/CT

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

Dec 2016

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

Jan 2017

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Dec 23, 2016

First Submission Date that Met QC Criteria

Dec 29, 2016

First Posted Date

Jan 2, 2017Estimated

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

Dec 29, 2016

Last Update Posted Date

Jan 2, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

yahua zhong, Director,oncology , Principal Investigator, Clinical Professor, Zhongnan HospitalPrincipal Investigator

Lead Sponsor

Zhongnan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol

Detailed Description

Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PET/CT	Device: PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Device	pet/ct is used as radiotherapy simulation	1

Measure	Description	Time Frame
progress free survival		baseline to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed oral squamous-cell carcinoma
Age > 17 years
Signed informed consent
ECOG Performance status 0-2
Must be able to start RT within 4 weeks after PET/CT simulation

Exclusion Criteria:

stage IV disease diagnosed before acquisition of staging PET/CT
prior radiotherapy to oral and neck
Unable to understand study participation
Claustrophobia
pregnant or breast feeding mothers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009062	Mouth Neoplasms

Ancestor Terms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072078	Positron Emission Tomography Computed Tomography

Ancestor Terms

ID	Term
D049268	Positron-Emission Tomography
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided