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JOURNAL ONKOLOGIE – STUDIE
GUARD

Tissue Retractors for Radiation Therapy of Head and Neck Tumors

Rekrutierend

NCT-Nummer:
NCT04454697

Studienbeginn:
Juli 2020

Letztes Update:
24.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Studienleiter

Sebastian Adeberg, PD
Principal Investigator
University Hospital Heidelberg

Kontakt

Jürgen Debus, Prof.
Kontakt:
Phone: +496221
Phone (ext.): 8021
E-Mail: juergen.debus@med.uni-heidelberg.de
» Kontaktdaten anzeigen
Adriane Hommertgen, Phd
Kontakt:
Phone: +496221
Phone (ext.): 8021
E-Mail: adriane.hommertgen@med.uni-heidelberg.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hopsital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jürgen Debus, MD PhD
Phone: +49 6221 56
Phone (ext.): 34093
E-Mail: juergen.debus@med.uni-heidelberg.de
» Ansprechpartner anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Toxcicity (Time Frame - immediately after completin of Radiotherapy):
Number of grade III toxcicity events



Secondary outcome:

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)

Studien-Arme

  • Experimental: Intervention
    Patient receive personalized 3D-printed GWR
  • Active Comparator: Control
    Patient receive standardized radiation protection tooth splints

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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