An interventional study of intraoperative navigation and creation of tumor resection maps in Head and Neck Tumors, sponsored by Juergen Debus. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Juergen Debus · Not applicable, Interventional, and Treatment
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Juergen Debus is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Safety of tumor resection
occurence of clear resection margins according to NCCN guidelines.
Time frame: within 24 month after radiotherapy
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.
Time frame: within 24 month after radiotherapy
distant tumor control
Distant progression is defined as progressive disease according to RECIST v1.1 outside the original tumor site
Time frame: 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
Time frame: within 24 month after radiotherapy
Overall survival
Overall survival is defined as the time interval from surgical resection until death
Time frame: 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
Time frame: within 24 month after radiotherapy
Started Jan 2023 (actual). Primary completion is estimated for Jan 2027, 48 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 48 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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Juergen Debus