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

Launched by JUERGEN DEBUS · Jan 2, 2023

Keywords

ClinConnect Summary

The NAVIGATORR trial is studying a new approach to improve treatment for patients with head and neck tumors, specifically focusing on making surgeries more precise and personalizing radiation therapy afterward. The goal is to ensure that the tumor is completely removed during surgery, which is defined as having clear margins (meaning no cancer cells are left at the edges of the removed tissue). By using advanced navigation techniques during surgery and sharing important information among the surgical team, the hope is to enhance local tumor control and improve overall survival rates.

To participate in this trial, you need to be at least 18 years old and have a specific type of head and neck cancer, such as squamous cell carcinoma or adenocarcinoma. You should also be able to undergo surgery and likely need additional radiation treatment afterward. If you join the study, you can expect to have surgery with new navigation methods, and your recovery will be closely monitored. It’s important to know that if you are pregnant or have certain medical conditions, you may not be eligible to participate. The trial is currently recruiting patients, and your involvement could contribute to important advancements in treating head and neck cancers.

Gender

ALL

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