Tissue Retractors for Radiation Therapy of Head and Neck Tumors

NCT04454697 | Completed

• 1 other identifier: GUARD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Toxcicity

  Number of grade III toxcicity events

  immediately after completin of Radiotherapy

Secondary Outcomes (2)

• Assesment of Quality of life: questionnaire

  up to 12 month after completion of radiotherapy

• Assesment of Quality of life: questionnaire

  up to 12 month after completion of radiotherapy

Study Arms (2)

Intervention

EXPERIMENTAL

Patient receive personalized 3D-printed GWR

Device: tissue retractors

Control

ACTIVE COMPARATOR

Patient receive standardized radiation protection tooth splints

Device: tissue retractors

Interventions

tissue retractors DEVICE

Patients receive a tissue retractor to spare healthy tissue during the course of radiation

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hopsital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (2)

• Schroter 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 DERIVED

• Held 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sebastian Adeberg, PD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 1, 2020
• Study Start: July 23, 2020
• Primary Completion: September 8, 2022
• Study Completion: October 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)