Actively Recruiting
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Led by University of Erlangen-Nürnberg Medical School · Updated on 2026-03-13
508
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to postoperative radiotherapy in patients with squamous cell carcinoma of the head and neck. This phase II/III multicenter trial aims to reduce long-term side effects of radiation by eliminating radiotherapy to the elective neck while maintaining strict surgical and radiological standards. The goal is to lower late toxicity without compromising locoregional cancer control. Participants will be randomly assigned to one of two groups: the control group will receive standard postoperative radiotherapy including elective nodal irradiation, while the investigational group will have radiotherapy targeted only to the primary tumor and affected lymph nodes without elective nodal irradiation. The study uses a two-stage design, starting with a phase II to measure 1-year feeding tube dependence followed by a phase III to assess locoregional control if initial results are favorable. During the study, participants will undergo radiotherapy according to their assigned group, followed by monitoring of outcomes such as feeding tube dependence, disease-free survival, overall survival, and toxicity levels. Researchers will use imaging and clinical assessments to track cancer recurrence and side effects. The study expects up to 26 months of follow-up to evaluate long-term effects and treatment success.
CONDITIONS
Brief Title
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven squamous cell carcinoma of the oral cavity, larynx, or oropharynx/hypopharynx (except glottis cancer pT1/2pN0)
- Surgery of primary tumor and neck dissection performed according to predefined surgical standards
- Indication for postoperative radiotherapy or radiochemotherapy
- No lymph node metastases larger than 6 cm
- Lymph node metastases in no more than 3 lymph node levels
- No distant metastases (cM0)
- Age 18 years or older, no upper age limit
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
- Ability to understand protocol and comply with study procedures
- Signed study-specific consent form before therapy
- Radiotherapy to start at least 6 weeks after last tumor-specific surgery (excluding surgeries for wound healing complications)
You will not qualify if you...
- Macroscopic incomplete tumor resection (R2)
- Presence of distant metastases (cM1)
- Early recurrence after surgery before radiotherapy start
- Lymph node metastases in more than 3 lymph node levels
- Pregnant or breastfeeding women
- Fertile patients unwilling to use effective contraception during treatment
- Conditions that may impair compliance with study protocol or follow-up
- Participation in other therapeutic clinical trials during treatment
- Prior tumor-specific therapy other than surgery (e.g. prior radiotherapy, chemo- or immunotherapy)
- Contraindications for MRI and contrast-enhanced CT scans
- Neck dissection or head and neck surgery affecting lymph drainage within 2 months before radiotherapy
- History of another primary cancer within 5 years except treated malignancies without active disease, or certain treated skin cancers without disease evidence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Starts at least 6 weeks after surgery and continues according to radiotherapy schedule
Participants receive postoperative radiotherapy to the head and neck region, either with or without elective nodal irradiation, to reduce radiation volume while maintaining treatment standards.
Multiple visits for radiotherapy sessions over several weeks
Duration - Up to 26 months
Participants are monitored for locoregional control, toxicity, and survival outcomes after completing radiotherapy.
Regular visits for assessments up to 26 months
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
M
Marlen Haderlein, PD
S
Studiensekretariat
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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