RecruitingPhase 2Phase 3NCT06030440

De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

508 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether reducing the intensity of radiation therapy after surgery for head and neck squamous cell cancer (a type of cancer affecting the mouth, throat, or voice box) is as safe and effective as standard radiation. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with squamous cell carcinoma of the mouth, throat, or voice box (certain locations) - You have had surgery to remove the tumor and lymph nodes - You have no cancer spread to distant organs - You are in good enough health to receive radiation therapy (ECOG score 0–2) - Radiation is planned to start at least 6 weeks after your surgery **You may NOT be eligible if...** - The cancer was not completely removed during surgery - The cancer has spread to distant parts of the body - You have cancer coming back after surgery (early recurrence) - You are pregnant or breastfeeding - You had radiation to the head and neck area before, or prior chemotherapy/immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONEliminating RT to the elective neck

Reduction of radiation volume by eliminating radiotherapy to the elective neck

RADIATIONRT standard of care

postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation


Locations(1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06030440


Related Trials