DRKS00016164
Recruiting
Phase 2
Proton therapy of tumors of the head and neck area: Prospective recording of efficiency and side effects at standard clinical doses - Proto-R-H
niversitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie0 sites456 target enrollmentDecember 20, 2018
ConditionsC01C02C03C04C05C06C07C08C09C10C11C12C13C14C80.0Malignant neoplasm of base of tongueMalignant neoplasm of other and unspecified parts of tongueMalignant neoplasm of gumMalignant neoplasm of floor of mouthMalignant neoplasm of palateMalignant neoplasm of other and unspecified parts of mouthMalignant neoplasm of parotid glandMalignant neoplasm of other and unspecified major salivary glandsMalignant neoplasm of tonsilMalignant neoplasm of oropharynxMalignant neoplasm of nasopharynxMalignant neoplasm of piriform sinusMalignant neoplasm of hypopharynxMalignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxMalignant neoplasm, primary site unknown, so stated
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C01
- Sponsor
- niversitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
- Enrollment
- 456
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Head and neck tumors: squamous cell carcinomas, adenocarcinomas, rare histologies
- •\- Age \> 18 years
- •\- ECOG \< 2
- •\- Indication for high\-dose primary radiotherapy or radiochemotherapy or for high\-dose adjuvant radiotherapy or radiochemotherapy
- •\- Treatment (radiation dose, additional systemic therapies) according to current clinical standard possible and planned
- •\- Ability to consent and the patient's present written consent
Exclusion Criteria
- •\- Lack of possibility of MRI planning (e.g. contraindications to performing an MRI)
- •\- Lack of patient compliance
- •\- Missing or limited possibility of reproducible positioning (e.g. due to severe limitation of patient mobility)
- •\- metals in the region to be irradiated (e.g. internal fixator in the affected section of the cervical spine) if they interfere with dose distribution
- •\- Tumors of the skull base or with irradiation area that reaches the skull base in large volume (\-\-\> include in Proto\-R skull base)
Outcomes
Primary Outcomes
Not specified
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