Feasibility Study of Incorporating 18F-FDG-PET Imaging in... | NCT00135161

Studies
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

NCT00135161

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 8, 2022Actual

Enrollment

40Estimated

Phase

Phase 1

Conditions

Head and Neck Neoplasms

Interventions

FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

Countries

Belgium

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 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003Actual

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Aug 24, 2005

First Submission Date that Met QC Criteria

Aug 24, 2005

First Posted Date

Aug 25, 2005Estimated

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 6, 2022

Last Update Posted Date

Dec 8, 2022Actual

Name	Class
Belgian Federation Against Cancer	OTHER

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

The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Detailed Description

The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensity modulated radiation therapy (IMRT).	Experimental		Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).	Procedure	FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).	Intensity modulated radiation therapy (IMRT).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy		until 3 months after the end of the radiotherapy
Observation of chronic toxicity		until 3 months after the end of the radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Therapy response (2-4 months after end of radiotherapy)		2-4 months after end of radiotherapy
Local control at 2 years		at 2 years
Pattern of recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
Patients who did not undergo surgery for the primary tumor location
Patients with a Karnofsky performance score of 70% or more
Written informed consent for participation in this trial

Exclusion Criteria:

Other malignancy except for non-melanoma skin cancer
Prior irradiation to the head and neck region

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wilfried De Neve, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided