Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05671458
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2022-12-16
Brief Title:
Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors
Sponsor:
Juergen Debus
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors - NAVIGATORR
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVIGATORR
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 chemoradiotherapy 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None