Health Trials

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

ConditionsSquamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the LarynxSquamous Cell Carcinoma of the HypopharynxSquamous Cell Carcinoma of the Oropharynx
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Eliminating RT to the elective neck
  • RT standard of care

Treatment groups

508 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Erlangen-Nürnberg Medical School

Lead sponsor

Source ClinicalTrials.gov