Proton therapy of tumors of the head and neck area: Prospective recording of efficiency and side effects at standard clinical doses
- Conditions
- C01C02C03C04C05C06C07C08C09C10
- Registration Number
- DRKS00016164
- Lead Sponsor
- niversitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 456
Head and neck tumors: squamous cell carcinomas, adenocarcinomas, rare histologies
- Age > 18 years
- ECOG < 2
- Indication for high-dose primary radiotherapy or radiochemotherapy or for high-dose adjuvant radiotherapy or radiochemotherapy
- Treatment (radiation dose, additional systemic therapies) according to current clinical standard possible and planned
- Ability to consent and the patient's present written consent
- Lack of possibility of MRI planning (e.g. contraindications to performing an MRI)
- Lack of patient compliance
- Missing or limited possibility of reproducible positioning (e.g. due to severe limitation of patient mobility)
- metals in the region to be irradiated (e.g. internal fixator in the affected section of the cervical spine) if they interfere with dose distribution
- Tumors of the skull base or with irradiation area that reaches the skull base in large volume (--> include in Proto-R skull base)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of late toxicity of a proton therapy with clinical standard doses and fractionation schemes<br><br>Primary target:<br>Grade III/ IV Late toxicity (CTCAE 4.0) 2 years after therapy
- Secondary Outcome Measures
Name Time Method Evaluation of local tumor control after proton therapy with clinical standard doses and fractionation schemes, evaluation of acute toxicity.<br><br>Secondary targets:<br>Local tumor control rate after 2 years<br>Overall survival after 2 years<br>Acute toxicity > Grade II<br>Late toxicity Grade II<br>