Tissue Retractors for Radiation Therapy of Head and Neck Tumors

Head and Neck Cancer Clinical Trial

— GUARD  

Official title:

Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454697
• Other study ID #: GUARD
• Status: Completed
• Phase: N/A
• Start date: July 23, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2023
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• tissue retractors
Patients receive a tissue retractor to spare healthy tissue during the course of radiation

Locations

Country	Name	City	State
Germany	University Hopsital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxcicity	Number of grade III toxcicity events	immediately after completin of Radiotherapy
Secondary	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
Secondary	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