Clinical trial · Interventional
Tissue Retractors for Radiation Therapy of Head and Neck Tumors
Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
- 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)
The rate of therapy-associated side effects during and after radiotherapy of head and neck tumors is essential. The most effective approach to reducing acute toxicity is to cut out healthy tissue from the radiation field. The distance between the tumor and normal tissue can be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. The current randomized phase II study evaluates the use of GWR with regard to acute toxicity. In addition, quality of life, long-term toxicity as well as local control and overall survival 12 months after radiotherapy are evaluated.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tissue retractors | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patient receive personalized 3D-printed GWR
- interventionNames
- Device: tissue retractors
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Patient receive standardized radiation protection tooth splints
- interventionNames
- Device: tissue retractors
Primary outcomes (1)
- measure
- Toxcicity
- timeFrame
- immediately after completin of Radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of a malignant head and neck tumor * Clinical target volume of radiotherapy may include portions of at least one region: oral cavity; Upper jaw; Lower jaw; Oropharynx; Hypopharynx; large salivary glands * Indication for radiotherapy alone (postoperative or definitive) * Age ≥ 18 years * Karnofsky performance score ≥ 60 * Completed wound healing after tumor resection * The patient's consent and written consent * Ability of the patient to assess the nature and scope as well as possible consequences of the clinical study * Adequate contraception in women of childbearing potential and in men Exclusion Criteria: * Pre-radiation in the head and neck area * Multifocal, diffuse growing tumors * Inadequate regression of toxicities from previous therapies * Jaw clamp (cutting edge distance ≤ 2 cm) * Simultaneous systemic tumor therapy during radiation (especially chemotherapy and immunotherapy) * Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance) * Missing written declaration of consent
References
Publications (2)
- DERIVEDSchroter P, Christ LV, Dvornikovich K, Stritzke F, Franke H, Weusthof K, Bauer L, Regnery S, Deng M, Behnisch R, Kolz TT, Herpel C, Tholken R, Schuler P, Moratin J, Ristow O, Rammelsberg P, Hoffmann J, Schwindling FS, Uzun-Lang K, Herfarth K, Adeberg S, Debus J, Held T. Randomized controlled trial of semi-individualized 3D-printed tissue retraction devices vs. standard shielding splints in head and neck cancer treated with intensity-modulated and particle radiotherapy (GUARD). Oral Oncol. 2025 Oct;169:107604. doi: 10.1016/j.oraloncology.2025.107604. Epub 2025 Aug 20. PMID 40840174
- DERIVEDHeld T, Herpel C, Schwindling FS, Christ L, Lang K, Regnery S, Eichkorn T, Hommertgen A, Jaekel C, Krisam J, Moratin J, Mrosek J, Metzger K, Zaoui K, Moutsis T, Harrabi S, Herfarth K, Freudlsperger C, Rammelsberg P, Debus J, Adeberg S. 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial. Radiat Oncol. 2021 Apr 17;16(1):75. doi: 10.1186/s13014-021-01803-8. PMID 33865401