Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05671458

Studienbeginn:
Januar 2023

Letztes Update:
28.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Juergen Debus

Collaborator:
-

Kontakt

Sebastian Adeberg, Prof. Dr.
Kontakt:
Phone: +49 6221 56 8202
E-Mail: sebastian.adeberg@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiotherapy, University of Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Juergen Debus, Prof. Dr. Dr.
Phone: +49 6221 56
Phone (ext.): 8200
E-Mail: juergen.debus@med.uni-heidelberg.de

Adriane Hommertgen, Dr. med.
Phone: 0622156
Phone (ext.): 34091
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The overarching goal of the NAVIGATORR trial is the improvement of local tumor control in

head-and-neck cancer (HNC) by increasing the precision of surgical resection and

individualization of radiotherapy. Squamous cell carcinomas (SCC) together with salivary

gland carcinomas (adenoid cysytic Carcinoma (ACC), mucoepidermoid Carcinoma (MEC),

adenocarcinoma (AC)) represent the most common entities in German head and neck oncology. In

localized tumors, primary tumor resection with possible adjuvant (chemo)radiotherapy is still

the treatment of choice. Advances in targeted therapy and immunotherapy have greatly expanded

the repertoire of medical oncology in recent years. In particular, prognosis of patients with

end-stage non-small cell lung cancer (NSCLC) has been improved and even patients with

advanced head and neck disease can be offered new second line regimes. Importantly, all of

these advances are based on personalized and targeted therapies. Unfortunately, surgical

oncology in the head-and-neck region has not yet shown such developments towards

individualized treatment, so that the rates of safe oncological resections (clear resection

margins) haven been stagnating. Despite advances in reconstructive surgery that allow the

resection of head-and-neck tumors that would not have been operable 10 - 15 years ago, the

basic principles of the resection margin and especially margin evaluation have remained

unchanged. The technique of navigation-based tumor resection and the annotation of biopsies

by titanium clip-markings or special annotation have been described, but only in small case

series and without proving the benefit of the method concerning clinically relevant

parameters.

Therefore, the NAVIGATORR trial will enroll 60 patients with HNC of the midface that will

undergo navigation-based surgery. Importantly, interdisciplinary data exchange of the

intraoperative navigation data between surgeons, pathologists and radiation oncologists will

be established. Clear surgical margins (distance between tumor cells and resection border > 5

mm) have been defined as primary endpoint. Secondary endpoints such as dosimetric assessment

of individualized radiotherapy plans, local tumor control or overall survival should then be

compared to data from the literature to further assess this multidisciplinary approach.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of a malignancy (squamous cell carcinoma (SCC), adenocarcinoma (AC),

mucoepidermoid carcinoma (MEC), adenoidcystic carcinoma (ACC)) of the midface, upper

jaw and skull-base (e.g. based on imaging-studies and/or biopsies)

- Indication of surgical tumor resection according to multidisciplinary tumor conference

- Probably indication for postoperative radiotherapy (e.g. T3/4 tumor)

- Medical operability and written informed consent of the patient to undergo surgical

resection (as indicated clinically)

- Patient age ≥ 18 years

- Karnofsky performance index ≥ 60%

- For women with childbearing potential: adequate contraception

- Ability of subject to understand character and individual consequences of the trial

- Written informed consent to participate in this trial

Exclusion Criteria:

- Contraindications against radiotherapy, especially pregnant or lactating women

- Refusal of the patient to take part in the study

- Participation in another competing clinical study or observation period of competing

trials

Studien-Rationale

Primary outcome:

1. Safety of tumor resection (Time Frame - within 24 month after radiotherapy):
occurence of clear resection margins according to NCCN guidelines.

Secondary outcome:

1. local tumor control (Time Frame - within 24 month after radiotherapy):
Local progression is defined as progressive disease at the original tumor site according to the Response Evaluation Criteria in Solid Tumors (RECIST) in the current version 1.1.

Geprüfte Regime

intraoperative navigation and creation of tumor resection maps:
TRM are based on intraoperative navigation data and yield anatomically accurate marks of the tumor resection margin and potential residual tumor areas on clinical imaging. These marks will be annotated with histopathological information. Subsequently, the resulting 3-dimensional TRM will be imported into the radiotherapy planning system as part of a multidisciplinary workflow.

Quelle: ClinicalTrials.gov

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