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

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ClinicalTrials.gov Identifier: NCT04454697
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: tissue retractors Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Toxcicity [ Time Frame: immediately after completin of Radiotherapy ]
    Number of grade III toxcicity events


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

  2. Assesment of Quality of life: questionnaire [ Time Frame: up to 12 month after completion of radiotherapy ]
    Changes of Parameters on the Core Quality of Life Questionnaire H&N35, scores 1 to 6 (best)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454697


Contacts
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Contact: Jürgen Debus, Prof. +496221 ext 8021 juergen.debus@med.uni-heidelberg.de
Contact: Adriane Hommertgen, Phd +496221 ext 8021 adriane.hommertgen@med.uni-heidelberg.de

Locations
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Germany
University Hopsital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, MD PhD    +49 6221 56 ext 34093    juergen.debus@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Sebastian Adeberg, PD University Hospital Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juergen Debus, Head of Department, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04454697    
Other Study ID Numbers: GUARD
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms