C07 C08 C41 D16 D48
Conditions
Interventions
Group 1: Chordoma: Proton radiotherapy 2,0 Gy (RBE)/ Fx, total dose 72-76 Gy (RBE)
Group 2: Chondrosarcoma with macroscopic tumour (residuum): Proton radiotherapy
2,0 Gy (RBE)/ Fx, total dose 70-72 Gy (RBE)
Group 3: Chondrosarcoma, marginal R0 or R1: Proton radiotherapy 2,0 Gy (RBE)/Fx, total dose 60-66 Gy (RBE)
Group 4: Salivary gland tumours, primary or incom
Sponsors
Universitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade III / IV toxicity (CTCAE 4.0) after 2 years; evaluation by one-sided one-sample binomial test with normal approximation | — |
Secondary
| Measure | Time frame |
|---|---|
| Local 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 | — |
Countries
Germany
Contacts
Public ContactAnnett Petzold
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
Outcome results
None listed