NCT06030440

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control. Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm) A two-stage design was chosen for this purpose. Phase II: A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first. Phase III: If the primary endpoint of the phase II study is met and the interim analysis shows no increase in the locoregional recurrence rate in the study/investigational arm, the study will be continued as a phase III study whose primary endpoint is the locoregional control rate.

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-26
• Primary completion: 2031-12-01
• Completion: 2033-09-01
• First posted: 2023-09-11
• Last updated: 2026-03-13

Locations

1 site across 1 country: Germany