Status:
COMPLETED
Tissue Retractors for Radiation Therapy of Head and Neck Tumors
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-99 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04454697
Start Date
July 23 2020
End Date
October 1 2023
Last Update
November 24 2023
Active Locations (1)
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1
University Hopsital Heidelberg
Heidelberg, Germany, 69120