NCT00135161

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

11.9 years

First QC Date

August 24, 2005

Last Update Submit

December 6, 2022

Conditions

Head and Neck Neoplasms

Keywords

neoplasms (squamous cell carcinoma of the head and neck region)

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • 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

    at 2 years

Study Arms (1)

Intensity modulated radiation therapy (IMRT).

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

Interventions

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).

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Wilfried De Neve, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

September 1, 2003

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

BE(1)