NCT02528955CompletedPhase 2
De-Intensification Radiotherapy Postoperative Head Neck
De-intensification of Postoperative Radiotherapy in Selected Patients With Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with \>= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and or R1/2 resection. Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia, fibrosis, trismus etc. The aim of this study is to investigate if depending on primary tumor stage, quality of resection ( resection margin) and number of lymph node metastasis and performed neck dissection an adapted de-intensified dose- and target volume concept may be performed without reducing locoregional-control but with reducing radiotherapy-related side-effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 10 Aug 2015
- Start date
- 1 Oct 2014
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Head and neck cancer
- NCT number
- NCT02528955
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 200
- From 1 Oct 2014 to the primary completion date, 31 Oct 2022
- 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
- R1 or R2 resection status
- prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction)
- time between surgery and beginning of radio(chemo)therapy \> 6 weeks
- Prior (\> 4 months before beginning of radio(chemo)therapy) neck dissection
Other illness
- Any condition potentially hampering compliance with the study protocol and follow-up schedule
Lab values
- In case of indicated simultaneous chemotherapy:
- reduced hearing ability (especially upper frequency range)
- known dihydropyrimidindehydrogenase (DPD) deficiency
- simultaneous therapy with brivudin or other DPD-inhibitors
- uncontrolled serious disease, including physical and mental diseases, for example within last 6 months:instable angina pectoris, heart attack, serious cardiac dysrhythmias, stroke, serious carotid stenosis, neurologic or psychiatric disorders including epilepsy, dementia, psychosis; uncontrolled infection; liver cirrhosis Child B or C, severe hepatic impairment; severe blood count changes; severe renal impairment, HIV
Other
- 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 trials
- pN2c and pN3
- cM1
Who the study is looking for
- Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx
- Postoperative tumor status:
- Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b
- Hypopharynx: pT1-2; pN1
- Patients that fulfill one or both of the following criteria:
- ≤ pT2, R ≥ 5 mm, L0, Pn0
- ≤ 3 ipsilateral lymph node metastases (if a contralateral adequate neck dissection is performed, no contralateral neck dissection is recommended in patients with strictly ipsilateral localised tumors of the oropharynx or oral cavity)
- R0-Resection (resection margin ≥ 1mm)
- No distant metastasis cM0
- age ≥ 18 years, no upper age limit
- ECOG ≤ 2
- Patients that understood protocol contents and are able to behave according to protocol
- Signed study-specific consent form prior to therapy
- In case of indicated simultaneous chemotherapy:
- adequate bone marrow function (leucocytes \> 3,5x10\^3, platelets \> 100x 10\^3, hemoglobin \> 10g/dl
- sufficient liver function: bilirubin \< 2,0mg/dl, ALT, AST \< less than 3 times upper limit of normal
- sufficient renal function: normal serum creatinine, glomerular filtration rate \> 60ml/min
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 |
|---|---|---|---|
| Dept. of Radiooncology, University Hospital Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
Related publications
- Exploratory immunomonitoring during radiochemotherapy in HNSCC and machine-learning reveal immune parameters associated with disease-free survival.NPJ Precis Oncol · 2026 · PMID 42675144
This page is information, not medical advice. Discuss any trial with your doctor.