search
Back to results

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

Primary Purpose

Head and Neck Tumors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intraoperative navigation and creation of tumor resection maps
Sponsored by
Juergen Debus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety of tumor resection
    occurence of clear resection margins according to NCCN guidelines.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    January 2, 2023
    Sponsor
    Juergen Debus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05671458
    Brief Title
    Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors
    Acronym
    NAVIGATORR
    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

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2027 (Anticipated)
    Study Completion Date
    January 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Juergen Debus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Tumors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    intraoperative navigation and creation of tumor resection maps
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Safety of tumor resection
    Description
    occurence of clear resection margins according to NCCN guidelines.
    Time Frame
    within 24 month after radiotherapy
    Secondary Outcome Measure Information:
    Title
    local tumor control
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    distant tumor control
    Description
    Distant progression is defined as progressive disease according to RECIST v1.1 outside the original tumor site
    Time Frame
    within 24 month after radiotherapy
    Title
    Progression-free survival
    Description
    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
    Title
    Overall survival
    Description
    Overall survival is defined as the time interval from surgical resection until death
    Time Frame
    within 24 month after radiotherapy
    Title
    Treatment-related toxicity
    Description
    Treatment-related side effects will be assessed clinically and radiographically according to the CTCAE version 5.0
    Time Frame
    within 24 month after radiotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sebastian Adeberg, Prof. Dr.
    Phone
    +49 6221 56 8202
    Email
    sebastian.adeberg@med.uni-heidelberg.de

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs