Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

Oropharyngeal Neoplasms Clinical Trial

Official title: Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

Status Recruiting

Clinical Trial Summary

To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.

Clinical Trial Description

Primary Objectives

To determine whether:

1. Omission of the contralateral neck cancer treatment is safe and toxicity-sparing for participants with well lateralized oropharyngeal HNSCC undergoing definitive or PORT radiation. This will be demonstrated by acceptably low contralateral neck failures (<15%)

Secondary Objectives

To determine:

1. the relative difference in symptom burden, as measured by the MDASI_HN area-under-the-toxicity curve (AUC), for initial surgical and initial non-surgical therapy cohorts.

2. Whether omission of the contralateral neck in radiotherapy planning as definitive of PORT treatment for well-lateralized oropharyngeal tumors will impact symptom burden as measured by MDASI AUC, Grade 2 or higher CTCAE v5.0 toxicity, swallow function, and/or feeding tube rates and dependency.

3. Risk adapted therapy approaches lead to differences in distant-metastasis-free survival (DMFS), ipsilateral neck failure, primary site failure, and whether salvage therapy for contralateral neck failures is feasible and effective compared to historical controls. ;

Related Conditions & MeSH terms

• Neoplasms
• Oropharyngeal Neoplasms

• NCT number: NCT06167291
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: David Rosenthal, MD
• Phone: (713) 563-2353
• Email: dirosenthal@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2024
• Completion date: December 9, 2027