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
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 confirmed 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 chemoradiotherapy
- No lymph node metastases larger than 6 cm
- Lymph node metastases limited to no more than 3 lymph node levels
- No distant metastases (cM0)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability to understand the study and follow the protocol
- Signed study-specific consent form before starting therapy
- Radiotherapy to start at least 6 weeks after last tumor 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 prior to start of radiotherapy or chemoradiotherapy
- Lymph node metastases in more than 3 lymph node levels
- Pregnant or nursing women
- Fertile patients unwilling to use effective contraception during treatment
- Any condition that may prevent following the study protocol or follow-up
- Participation in other therapeutic clinical trials during treatment
- Prior tumor-specific therapy other than surgery (e.g., prior head and neck radiotherapy, chemotherapy, or immunotherapy)
- Contraindication to MRI and CT with contrast agents
- Prior neck dissection or head and neck surgery affecting lymph drainage performed more than 2 months before radiotherapy start
- History of other primary cancers unless treated curatively with no active disease for at least 5 years, or adequately treated non-melanoma skin cancer or carcinoma in situ without active disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
M
Marlen Haderlein, PD
CONTACT
S
Studiensekretariat
CONTACT
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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