NCT06030440RecruitingPhase 2/3
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 508 (estimated)
- First submitted
- 11 Aug 2023
- Start date
- 26 Jan 2024
- Primary completion date
- Dec 2031
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Head and neck cancer
- NCT number
- NCT06030440
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 508
- From 26 Jan 2024 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any condition potentially hampering compliance with the study protocol and follow-up schedule
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Erlangen, Strahlenklinik Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.