Clinical trial · Interventional
De-Intensification Radiotherapy Postoperative Head Neck
De-intensification of Postoperative Radiotherapy in Selected Patients With Head and Neck Cancer
NCT02528955CI-TRIAL-00120058DIREKHTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A: De-Intensification RT primary tumor region | Radiation | — | UNRESOLVED |
| B: De-Intensification RT contralateral lymph nodes | Radiation | — | UNRESOLVED |
| C. De-Intensification RT primary tumor region AND contralateral lymph nodes | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A:De-Intensification Radiotherapy (RT) primary tumor region
- description
- A:De-Intensification Radiotherapy (RT) primary tumor region * ≤ pT2, R ≥ 5 mm, L0, Pn0 * \> 3 lymph node metastasis or patients with \< 3 ipsilateral lymph node metastasis and a bilateral primary tumor without adequate contralateral neck dissection
- interventionNames
- Radiation: A: De-Intensification RT primary tumor region
- type
- ACTIVE_COMPARATOR
- label
- B:De-Intensification Radiotherapy contralateral lymph nodes
- description
- * \> pT2 and/or R \< 5mm and/or L1 and/or Pn1 * ≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (\>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( \>= 5 mm distance from midline) cancer of the oral cavity or oropharynx
- interventionNames
- Radiation: B: De-Intensification RT contralateral lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx
2. Postoperative tumor status:
* Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b
* Hypopharynx: pT1-2; pN1
3. 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)
4. R0-Resection (resection margin ≥ 1mm)
5. No distant metastasis cM0
6. age ≥ 18 years, no upper age limit
7. ECOG ≤ 2
8. Patients that understood protocol contents and are able to behave according to protocol
9. Signed study-specific consent form prior to therapy
10. 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
Exclusion Criteria:
1. pregnant or lactating/nursing women
2. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
3. Any condition potentially hampering compliance with the study protocol and follow-up schedule
4. On-treatment participation on other trials
5. R1 or R2 resection status
6. pN2c and pN3
7. cM1
8. prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction)
9. time between surgery and beginning of radio(chemo)therapy \> 6 weeks
10. Prior (\> 4 months before beginning of radio(chemo)therapy) neck dissection
11. 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, HIVReferences
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Anna-Jasmina Donaubauer, Oliver Tomic, Lia Mogge et al. · NPJ Precis Oncol · Aug 31, 2026 · PMID 42675144 pubmed
- DERIVEDDonaubauer AJ, Tomic O, Mogge L, Muller SK, Futsaether CM, Liland KH, Huynh BN, von der Grun J, Balermpas P, Fleischmann M, Hautmann MG, Steger F, Bohr C, Hehr T, Stromberger C, Budach V, Schymalla M, Engenhart-Cabillic R, Kocik L, Geinitz H, Nestle U, Klautke G, Scherl C, Schubert P, Corradini S, Fietkau R, Gaipl US, Frey B, Haderlein M. Exploratory immunomonitoring during radiochemotherapy in HNSCC and machine-learning reveal immune parameters associated with disease-free survival. NPJ Precis Oncol. 2026 Aug 31;10(1):337. doi: 10.1038/s41698-026-01658-w. PMID 42675144
- DERIVEDHaderlein M, Speer S, Ott O, Lettmaier S, Hecht M, Semrau S, Frey B, Scherl C, Iro H, Kesting M, Fietkau R. Dose Reduction to the Swallowing Apparatus and the Salivary Glands by De-Intensification of Postoperative Radiotherapy in Patients with Head and Neck Cancer: First (Treatment Planning) Results of the Prospective Multicenter DIREKHT Trial. Cancers (Basel). 2020 Feb 26;12(3):538. doi: 10.3390/cancers12030538.