Proton therapy of children: Prospective collection of effectiveness and side effects with standard clinical doses
- Conditions
- Cancer in children with an indication for radiotherapy
- Registration Number
- DRKS00011529
- Lead Sponsor
- niversitätsklinikum Carl Gustav Carus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Brain tumor: gliomas (low or high grade), ependymomas, medulloblastomas, meningiomas, pituitary adenomas, craniopharyngeomas and other rare brain tumors as well as AV malformations
- Extracerebral malignant tumors
- ECOG = 2
- Indication for curative or long-term palliative radiotherapy or radiochemotherapy
- Written consent of the legal representative(s), and child in addition in case of cognitive faculty
- Lack of capacity to consent or lack of written consent of the patient
- Lack of adequate planning (e.g., contraindications to performing MRI if MRI is indicated for proton therapy)
- Lack of compliance for the evaluation of endpoints (toxicity and quality of life)
- Contraindication against the performance of a proton therapy, e.g. mobility of the region or the surrounding organs, if a reliable and reproducible target volume detection or preservation of the normal tissue can not be ensured
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life after 2 years compared to the value before radiotherapy.
- Secondary Outcome Measures
Name Time Method - local tumor control after 2 years<br>- acute toxicity >= CTCAE 4.0 grade 2<br>- overall survival after 2 years<br>- chronic toxicity >= CTCAE 4.0 grade 2 after 2 years<br>- follow-up and evaluation of all primary and secondary endpoints after 5 and 10 years