Tissue Retractors for Radiation Therapy of Head and Neck Tumors (GUARD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: tissue retractors

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University Hopsital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patient receive personalized 3D-printed GWR	Device: tissue retractors; Patients receive a tissue retractor to spare healthy tissue during the course of radiation
Active Comparator: Control; Patient receive standardized radiation protection tooth splints	Device: tissue retractors; Patients receive a tissue retractor to spare healthy tissue during the course of radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxcicity	Number of grade III toxcicity events	immediately after completin of Radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of Quality of life: questionnaire	Changes of Parameters on the Core Quality of Life Questionnaire C30, scores 1 to 6 (best)	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)	up to 12 month after completion of radiotherapy

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Sebastian Adeberg, PD, University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): September 8, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: GUARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No