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De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck — DIREKHT2  

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma of the Hypopharynx
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Oropharynx
Clinical Trial Details
NCT number NCT06030440
Study type Interventional
Source University of Erlangen-Nürnberg Medical School
Contact Marlen Haderlein, PD
Phone +49913185
Email marlen.haderlein@uk-erlangen.de
Status Recruiting
Phase Phase 2/Phase 3
Start date January 26, 2024
Completion date September 2033
View Details
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