Head and Neck CancerGUARDNCT04454697
Tissue Retractors for Radiation Therapy of Head and Neck Tumors
A study testing tissue retractors in people with Head and Neck Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- tissue retractors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jul 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
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.
Read the detailed description
The most effective approach to reducing acute toxicity after radiotherapy is to cut out healthy tissue from the radiation field. GWR can increase the distance between the tumor and normal tissue. Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. Adequate immobilization also reduces unwanted movements, especially of the tongue.
The GWR are manufactured as combinable modules according to the "modular principle". This improves reproducibility and flexibility and reduces development and manufacturing costs. The study is being conducted as a monocentric, prospective, randomized phase II study. A total of 34 patients who meet the inclusion criteria are examined for acute toxicity after radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals are the evaluation of quality of life and long-term toxicity as well as local control and overall survival twelve months after radiotherapy. In both groups, radiation therapy is carried out in accordance with guidelines using image-guided radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- tissue retractors
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue retractorsDevice
Patients receive a tissue retractor to spare healthy tissue during the course of radiation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patient receive personalized 3D-printed GWR Receives: Device: tissue retractors |
| Control | Active comparator | Patient receive standardized radiation protection tooth splints Receives: Device: tissue retractors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxcicity
Number of grade III toxcicity events
Measured: immediately after completin of Radiotherapy
Secondary outcomes (2)
Assesment of Quality of life: questionnaire
Changes of Parameters on the Core Quality of Life Questionnaire C30, scores 1 to 6 (best)
Measured: up to 12 month after completion of radiotherapy
Assesment of Quality of life: questionnaire
Changes of Parameters on the Core Quality of Life Questionnaire H\&N35, scores 1 to 6 (best)
Measured: up to 12 month after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start23 Jul 2020
- Primary completion8 Sep 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Sebastian Adeberg, PD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454697
- Sponsor's protocol ID
- GUARD
- Acronym
- GUARD
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40840174Held 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.
PubMed 33865401
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
- ClinicalTrials.gov ID
- NCT04454697
- Acronym / sponsor ID
- GUARD / GUARD
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The most effective approach to reducing acute toxicity after radiotherapy is to cut out healthy tissue from the radiation field. GWR can increase the distance between the tumor and normal tissue. Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. Adequate immobilization also reduces unwanted movements, especially of the tongue.
The GWR are manufactured as combinable modules according to the "modular principle". This improves reproducibility and flexibility and reduces development and manufacturing costs. The study is being conducted as a monocentric, prospective, randomized phase II study. A total of 34 patients who meet the inclusion criteria are examined for acute toxicity after radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals are the evaluation of quality of life and long-term toxicity as well as local control and overall survival twelve months after radiotherapy. In both groups, radiation therapy is carried out in accordance with guidelines using image-guided radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: tissue retractorsPatient receive personalized 3D-printed GWR |
| Control | Active comparator | Device: tissue retractorsPatient receive standardized radiation protection tooth splints |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue retractorsPatients receive a tissue retractor to spare healthy tissue during the course of radiation | Device | Control, Intervention |
Primary outcome
Toxcicity
Time frame: immediately after completin of Radiotherapy
Number of grade III toxcicity events
2 secondary outcomes
Assesment of Quality of life: questionnaire
Time frame: up to 12 month after completion of radiotherapy
Assesment of Quality of life: questionnaire
Time frame: up to 12 month after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 40840174Schroter 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.
- Derived from this study: PubMed 33865401Held 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Adeberg, PD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tissue retractors in people with Head and Neck Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxcicity (time frame: immediately after completin of Radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.