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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00007534
Date of registration:	04/12/2014
Prospective Registration:	No
Primary sponsor:	Departement für Mund Kiefer Gesichtschirurgie
Public title:	Visualization of tumor resection margins for planning of radiation treatment in head & neck cancer surgery
Scientific title:	Visualization of tumor resection margins for planning of radiation treatment in head & neck cancer surgery - tumormarking
Date of first enrolment:	01/12/2012
Target sample size:	100
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00007534
Study type:	interventional
Study design:	Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Gido Bittermann
Address:	Hugstetter Str. 55 79106 Freiburg Germany
Telephone:	0049 761 270 47010
Email:	gido.bittermann@uniklinik-freiburg.de
Affiliation:	Uniklinik Freiburg, MKG

Name:	Gido Bittermann
Address:	Higstetter Str. 55 79106 Freiburg Germany
Telephone:	0049 761 270 47010
Email:	gido.bittermann@uniklinik-freiburg.de
Affiliation:	Uniklinik Freiburg, MKG

Key inclusion & exclusion criteria

Inclusion criteria: oral squamous cell carcinoma and planned adjuvant radiation therapy
Exclusion criteria: primary radiochemotherapy

Age minimum: None
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Malignant neoplasm of accessory sinuses

Malignant neoplasm of gum

C31
C00
C01
C03

Malignant neoplasm of base of tongue

Malignant neoplasm of lip

Intervention(s)

Group 1: marking of tumor resection margins after complete tumor removal with 6 titanium clips (Ethicon Endo-Surgery, Ligaclip Extra Titanium Medium) and the intro-operative navigation,
postoperative routine CT imaging,
image fusion of preoperative and postoperative datasets
Evaluation of the clips and the navigation points, delineation of the tumor resection margin
Transmission of data to the radiation oncologist and planning of adjuvant radiotherapy
Determination of the clip movement in function of the time
Comparison clip and navigated points
regular routine CT examination in the course,
Repetition of the evaluation points

Primary Outcome(s)

Occurrence of a relapse to tumor after finished of radiotherapy, control by routine CT examination

Secondary Outcome(s)

overal survival

Secondary ID(s)

Source(s) of Monetary Support

Department of Oral and Maxillofacial Surgery

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 26/11/2012
Contact:

ekfr.mpg@uniklinik-freiburg.de

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

+49-761-27072600

ekfr.mpg@uniklinik-freiburg.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00007534#studyResults

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