Clinical trial NCT05671458: Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors
Official title: Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors - NAVIGATORR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Tumors
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of tumor resection
timeFrame: within 24 month after radiotherapy
Secondary outcomes:
measure: local tumor control
timeFrame: within 24 month after radiotherapy
Other outcomes:
measure: distant tumor control
timeFrame: within 24 month after radiotherapy
measure: Progression-free survival
timeFrame: within 24 month after radiotherapy
measure: Overall survival
timeFrame: within 24 month after radiotherapy
measure: Treatment-related toxicity
timeFrame: within 24 month after radiotherapy
Locations:
city: Heidelberg
country: Germany
facility: Department of Radiotherapy, University of Heidelberg
Study officials:
References: