Clinical trial · Interventional
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
NCT06030440CI-TRIAL-00105425DIREKHT2recruitingPhase 2 / Phase 3ClinicalTrials.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)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eliminating RT to the elective neck | Radiation | — | UNRESOLVED |
| RT standard of care | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
- interventionNames
- Radiation: RT standard of care
- type
- EXPERIMENTAL
- label
- Investigational Arm
- description
- postoperative radiotherapy of the head and neck region without elective nodal irradiation
- interventionNames
- Radiation: Eliminating RT to the elective neck
Primary outcomes (2)
- measure
- Phase II: 1-year PEG feeding tube dependence rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0)) 2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard 3. Indication for postoperative radio(chemo)therapy 4. No lymph node metastases \> 6cm 5. Lymph node metastases in not more than 3 lymph node level 6. No distant metastases (cM0) 7. Age ≥ 18 years, no upper age limit 8. Eastern Cooperative Oncology Group (ECOG) ≤ 2 9. Patients who understood protocol contents and are able to behave according to protocol 10. Signed study-specific consent form prior to therapy 11. 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) Exclusion Criteria: 1. macroscopic incomplete resection R2 2. Distant metastases (cM1) 3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy) 4. Lymph node metastases in \> 3 lymph node level 5. pregnant or lactating/nursing women 6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment 7. Any condition potentially hampering compliance with the study protocol and follow-up schedule 8. On-treatment participation on other clinical therapeutic trials 9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction)) 10. Patients who have contraindication for MRI and CT with contrast agent (both) 11. Prior (\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage 12. 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
References
Publications (0)
Data not yet available
No reference posted for this study.