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.
Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
Surgery of primary tumor and neck dissection performed according to predefined surgical standard
Indication for postoperative radio(chemo)therapy
No lymph node metastases > 6cm
macroscopic incomplete resection R2
Distant metastases (cM1)
Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
Lymph node metastases in > 3 lymph node level
Parallel
Eliminating RT to the elective neck
RadiationReduction of radiation volume by eliminating radiotherapy to the elective neck
RT standard of care
Radiationpostoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
Phase II: 1-year PEG feeding tube dependence rate
observe change of PEG-dependence due to different target volumes
Phase III: Time to local relapse
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)
Disease-free survival
Disease-free survival
Distant-metastasis-free survival
Distant-metastasis-free survival
Overall survival (OS)
Overall survival (OS)
Cause of death (tumor-related, not tumor-related)
Cause of death (tumor-related, not tumor-related)
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