NCT03008694

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

December 23, 2016

Last Update Submit

December 29, 2016

Conditions

Oral CancerRadiotherapy; Complications

Keywords

PET/CT

Outcome Measures

Primary Outcomes (1)

  • progress free survival

    baseline to 2 years

Study Arms (1)

1

EXPERIMENTAL

PET/CT

Device: PET/CT

Interventions

PET/CTDEVICE

pet/ct is used as radiotherapy simulation

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,oncology , Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

January 2, 2017

Record last verified: 2016-12