Trial document





This trial has been registered retrospectively.
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  DRKS00008569

Trial Description

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Title

Proton therapy of skull base tumors : Prospective collection of effectiveness and side effects with standard clinical doses

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Trial Acronym

Proto-R-Schädelbasis

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Radiotherapy with protons has compared to standard radiotherapy with photons the physical advantage of a lower burden of the surrounding healthy tissue with middle and low radiation doses. Clinical data show high local tumor control rates after proton or heavy ion therapy, primarily due to the possibility of the application of relatively high doses of radiation with these treatment modalities. The toxicity of proton radiotherapy in patients with skull base tumors has not been adequately studied so far.
The main objective of the study is the investigation of proton therapy in terms of side effects. Patients with skull base tumors in which radiotherapy with the aim of tumor cure (or long-term tumor control) is shown, receive a proton therapy with total doses and fractionation according to proton radiotherapy standards already established standards by other centers. These schemes generally also correspond to the aspired dose and fractionation in photon therapy, however, they are often unreachable with photons because of the poorer dose distribution. A simultaneous chemotherapy may be administered as clinically indicated analogous to photon therapy.

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Brief Summary in Scientific Language

Patients with skull base tumors and indication for curative or high-dose palliative radiotherapy receive a proton therapy. Total doses and fractionation schemes are prescribed similar to the clinical standard. A simultaneous chemotherapy is allowed if clinically indicated.

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Organizational Data

  •   DRKS00008569
  •   2015/05/21
  •   [---]*
  •   yes
  •   Approved
  •   EK272072014, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C07 -  Malignant neoplasm of parotid gland
  •   C08 -  Malignant neoplasm of other and unspecified major salivary glands
  •   C41 -  Malignant neoplasm of bone and articular cartilage of other and unspecified sites
  •   D16 -  Benign neoplasm of bone and articular cartilage
  •   D48 -  Neoplasm of uncertain or unknown behaviour of other and unspecified sites
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Interventions/Observational Groups

  •   Chordoma: Proton radiotherapy 2,0 Gy (RBE)/ Fx, total dose 72-76 Gy (RBE)
  •   Chondrosarcoma with macroscopic tumour (residuum): Proton radiotherapy; 2,0 Gy (RBE)/ Fx, total dose 70-72 Gy (RBE)
  •   Chondrosarcoma, marginal R0 or R1: Proton radiotherapy 2,0 Gy (RBE)/Fx, total dose 60-66 Gy (RBE)
  •   Salivary gland tumours, primary or incompletely resected: Proton radiotherapy 2,0 Gy (RBE)/Fx, total dose 70-72 Gy (RBE)
  •   Salivary gland tumours, completely resected: Proton radiotherapy 2,0 Gy (RBE)/Fx, total dose 66 Gy (RBE)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Grade III / IV toxicity (CTCAE 4.0) after 2 years; evaluation by one-sided one-sample binomial test with normal approximation

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/12/01
  •   118
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Universitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof. Dr. med.  Mechthild  Krause 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof. Dr. med.  Mechthild  Krause 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.