Testing whether neck radiotherapy can be skipped after surgery for head and neck cancer
Tests skipping neck radiotherapy after surgery in adults with head and neck cancer.
Plain-language title generated from the registry record
Registry title: De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Key facts
- Where
- Erlangen, GermanySee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with squamous cell carcinoma of the mouth, larynx, throat or lower throat. They have had surgery and need radiotherapy afterwards. It tests leaving out radiation to the neck areas with no visible disease.
- Age
- 18 years or older, no upper age limit
- Sex
- All
- Disease stage
- Squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx (except glottis cancer pT1/2pN0). Lymph node spread no larger than 6cm (2.4 in) and in no more than 3 lymph node levels. No distant metastases (cM0).
- Earlier treatment
- Surgery of the main tumor and neck dissection done to a set standard. Radiotherapy starts at least 6 weeks after the last tumor-specific surgery. No earlier radiotherapy to the head and neck, and no earlier chemotherapy or immunotherapy.
Main reasons for not taking part
- Tumor not fully removed (macroscopic incomplete resection R2)
- Distant metastases (cM1)
- Cancer already back after surgery
- Pregnant or breastfeeding
- Cannot have both MRI and CT with contrast agent
Read by machine on 9 November 2026.
Where in Germany
- Universitätsklinikum Erlangen, StrahlenklinikErlangen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Erlangen-Nürnberg Medical School
- Trial code
- NCT06030440
- Record updated
- 13 March 2026
- Original description
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.Read full original descriptionShow less
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
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.
Inclusion: 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; Lymph node metastases in not more than 3 lymph node level; No distant metastases (cM0); Age ≥ 18 years, no upper age limit; Eastern Cooperative Oncology Group (ECOG) ≤ 2; Patients who understood protocol contents and are able to behave according to protocol; Signed study-specific consent form prior to therapy; Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications).
Exclusion: macroscopic incomplete resection R2; Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy); Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction)); Prior (> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage; History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease; Any condition potentially hampering compliance with the study protocol and follow-up schedule; Distant metastases (cM1); Lymph node metastases in > 3 lymph node level; pregnant or lactating/nursing women; fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment; On-treatment participation on other clinical therapeutic trials; Patients who have contraindication for MRI and CT with contrast agent (both).