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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Tumors
• Intervention / Treatment: Other: intraoperative navigation and creation of tumor resection maps

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Adeberg, Prof. Dr.; Phone Number: +49 6221 56 8202; Email: sebastian.adeberg@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Department of Radiotherapy, University of Heidelberg
    • Contact: Juergen Debus, Prof. Dr. Dr.; Phone Number: 8200 +49 6221 56; Email: juergen.debus@med.uni-heidelberg.de
    • Contact: Adriane Hommertgen, Dr. med.; Phone Number: 34091 0622156; Email: adriane.hommertgen@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of tumor resection	occurence of clear resection margins according to NCCN guidelines.	within 24 month after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local tumor control	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.	within 24 month after radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
distant tumor control	Distant progression is defined as progressive disease according to RECIST v1.1 outside the original tumor site	within 24 month after radiotherapy
Progression-free survival	Progression-free survival is defined as the time interval from surgical resection until the day of a progressive disease according to RECIST v1.1 at any site or death of any cause	within 24 month after radiotherapy
Overall survival	Overall survival is defined as the time interval from surgical resection until death	within 24 month after radiotherapy
Treatment-related toxicity	Treatment-related side effects will be assessed clinically and radiographically according to the CTCAE version 5.0	within 24 month after radiotherapy

Collaborators and Investigators

• Sponsor: Juergen Debus

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: NAVIGATORR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No