Proton therapy of skull base tumors : Prospective collection of effectiveness and side effects with standard clinical doses
Not Applicable
Recruiting
- Conditions
- C07C08C41D16D48Malignant neoplasm of parotid glandMalignant neoplasm of other and unspecified major salivary glandsMalignant neoplasm of bone and articular cartilage of other and unspecified sitesBenign neoplasm of bone and articular cartilageNeoplasm of uncertain or unknown behaviour of other and unspecified sites
- Registration Number
- DRKS00008569
- 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
- 118
Inclusion Criteria
skull base tumor: chordomas, chondrosarcomas, salivary gland carcinomas (e.g. adenoid cystic carcinomas)
- ECOG <= 2
- Indication for high-dose radiotherapy
- Capacity to consent and written consent of the patient
Exclusion Criteria
- Lack of capacity to consent or lack of written consent of the patient
- Inability to MRI planning (eg. contraindications to performing MRI)
- Lack of compliance of the patient
- Lack of or limited possibility of a reproducible positioning (eg by severe restriction of mobility of the patient)
- Metals in the region to be irradiated (e.g. internal fixator in the affected section of the cervical spine), if they disturb the dose distribution
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade III / IV toxicity (CTCAE 4.0) after 2 years; evaluation by one-sided one-sample binomial test with normal approximation
- Secondary Outcome Measures
Name Time Method ocal tumor control, overall survival, acute toxicity >= grade II and late toxicity grade II after 2 years in each case; evaluation by single-sided one-sample binomial test with normal approximation