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

NCT06030440 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Hypopharynx
  • Squamous Cell Carcinoma of the Oropharynx

Interventions

RADIATION

Eliminating RT to the elective neck

Reduction of radiation volume by eliminating radiotherapy to the elective neck

RADIATION

RT standard of care

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

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Sarina Müller, PD · Universitätsklinikum Erlangen, HNO

  • Rainer Fietkau, Prof · Universitätsklinikum Erlangen, Radiation Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2031-12-31
Completion
2033-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030440 on ClinicalTrials.gov