NCT04454697

Tissue Retractors for Radiation Therapy of Head and Neck Tumors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	tissue retractors	Patients receive a tissue retractor to spare healthy tissue during the course of radiation

Timeline

• Start date: 2020-07-23
• Primary completion: 2022-09-08
• Completion: 2023-10-01
• First posted: 2020-07-01
• Last updated: 2023-11-24

Locations

1 site across 1 country: Germany