NCT00528294

Brief Summary

This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2014

Enrollment Period

8.6 years

First QC Date

September 11, 2007

Last Update Submit

December 15, 2022

Conditions

Head and Neck Tumors

Keywords

Recurrent head and neck tumors

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose.

    3 months after end of treatment

  • Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.

    1 year.

Study Arms (1)

1

EXPERIMENTAL

GRID-radiotherapy followed by biological imaging guided IMRT

Radiation: GRID radiotherapy

Interventions

GRID radiotherapyRADIATION

GRID-radiotherapy followed by biological imaging guided IMRT

1

Eligibility Criteria

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

You may qualify if:

  • Recurrent or new head or neck tumor
  • years or older

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 20, 2022

Record last verified: 2014-12

Locations

BE(1)