Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

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

postoperative radiotherapy of the head and neck region without elective nodal irradiation

Reduction of radiation volume by eliminating radiotherapy to the elective neck

Eliminating RT to the elective neck

RT standard of care

Marlen Haderlein, PD

Studiensekretariat

Rainer Fietkau, Prof

Sarina Müller, PD

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.

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.

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

observe change of PEG-dependence due to different target volumes

difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)

Cause of death (tumor-related, not tumor-related)

Acute toxicity according to CTC version 5.0

Late toxicity according to CTC version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck	NCT06030440	Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C...	Eliminating RT ... RT standard of ...	18 Years -	University of Erlangen-Nürnberg Medical School
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck	NCT06030440	Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C...	Eliminating RT ... RT standard of ...	18 Years -	University of Erlangen-Nürnberg Medical School

Spots Global Cancer Trial Database for eliminating rt to the elective neck