NCT00406289

Brief Summary

This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration 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

November 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 6, 2010

Status Verified

September 1, 2010

Enrollment Period

2.8 years

First QC Date

November 30, 2006

Last Update Submit

September 3, 2010

Conditions

Head and Neck Tumor

Outcome Measures

Primary Outcomes (1)

  • Tumor recurrences

Interventions

18F-FDG-PET radiotherapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Head and neck tumor
  • Aged \> 18 years

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 Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

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

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

September 6, 2010

Record last verified: 2010-09

Locations

BE(1)