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Tissue Retractors for Radiation Therapy of Head and Neck Tumors

NCT04454697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-11-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

tissue retractors

Patients receive a tissue retractor to spare healthy tissue during the course of radiation

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Sebastian Adeberg, PD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-23
Primary Completion
2022-09-08
Completion
2023-10-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454697 on ClinicalTrials.gov