Cancer in children with an indication for radiotherapy
Conditions
Interventions
Group 1: Brain Tumors:
a - supratentorial tumors, proton therapy, no whole-brain irradiation, local dose greater than or equal 40 Gy (RBE)
b - supratentorial tumors, proton therapy, no brain irradiati
Sponsors
Universitätsklinikum Carl Gustav Carus
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life after 2 years compared to the value before radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - local tumor control after 2 years - acute toxicity >= CTCAE 4.0 grade 2 - overall survival after 2 years - chronic toxicity >= CTCAE 4.0 grade 2 after 2 years - follow-up and evaluation of all primary and secondary endpoints after 5 and 10 years | — |
Countries
Germany
Contacts
Public ContactAnnett Petzold
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
Outcome results
None listed