Proton therapy of tumors of the head and neck area: Prospective recording of efficiency and side effects at standard clinical doses

Proton therapy of tumors of the head and neck area: Prospective recording of efficiency and side effects at standard clinical doses - Proto-R-HN

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016164

Enrollment

456

Registered

2018-12-20

Start date

2019-01-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C01 C02 C03 C04 C05 C06 C07 C08 C09 C10 C11 C12 C13 C14 C80.0

Interventions

Group 1: 1) primary radiochemotherapy, complete with proton proton therapy Group 2: 2) adjuvant radiochemotherapy, complete with protons Group 3: 3) adjuvant radiotherapy, complete with protons Group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
Evaluation of late toxicity of a proton therapy with clinical standard doses and fractionation schemes Primary target: Grade III/ IV Late toxicity (CTCAE 4.0) 2 years after therapy	—

Secondary

Measure	Time frame
Evaluation of local tumor control after proton therapy with clinical standard doses and fractionation schemes, evaluation of acute toxicity. Secondary targets: Local tumor control rate after 2 years Overall survival after 2 years Acute toxicity > Grade II Late toxicity Grade II	—

Countries

Germany

Contacts

Public ContactAnnett Petzold

Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum

str.studien@uniklinikum-dresden.de0351-458 2238

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 9, 2026