A prospective, randomized comparative study of intensity-modulated radiation therapy (IMRT) with proton boost versus standard IMRT in the treatment of head and neck tumors

A prospective, randomized comparative study of intensity-modulated radiation therapy (IMRT) with proton boost versus standard IMRT in the treatment of head and neck tumors - HEAT-PRO HNSCC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039351

Enrollment

180

Registered

2026-03-05

Start date

2026-06-30

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

ICD-10-GM: C00-C06, C09-C14, C30-C32

Interventions

Group 1: Standard IMRT with a total dose of up to 66-70 Gy in 33-35 fractions over seven weeks. Group 2: Standard IMRT (50 Gy in 25 fractions over 5 weeks) plus pre- or post-boost with protons (up to

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Histologically confirmed head and neck tumor - Clinical stage I-IVB - Indication for chemoradiotherapy with a total radiation dose of up to 66–70 Gy (RBE) - Age = 18 years - ECOG performance status: 0-2 - Ability to provide informed consent - Adequate organ function according to laboratory tests - Willingness to complete quality of life questionnaires and attend regular study visits - Availability of a written informed consent form

Exclusion criteria

Exclusion criteria: - Malignant neoplasm of the parotid gland (ICD10: C07) or malignant neoplasm of unspecified major salivary glands (ICD10: C08) - Previous radiation therapy in the head and neck area - Presence of histologically proven metastatic disease - Simultaneous participation in another clinical trial that conflicts with this trial - Pregnancy or breastfeeding - unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Frequency of acute toxicities (mucositis, xerostomia, dysphagia, and weight loss) grade = 2 (from start of radiotherapy to 12 weeks after end of radiotherapy)	—

Secondary

Measure	Time frame
- Long-term survival and tumor control: disease-specific survival (DSS), overall survival (OS), local control (LC), and locoregional control (LRC) - Quality of life: disease-specific quality of life according to EORTC-QLQ-C30 and QLQ-HN43 - Long-term toxicities: Frequency of late toxicities grade = 2 toxicities (12 weeks after end of RT until end of follow-up) - Dependence on percutaneous endoscopic gastrostomy (PEG) - Identification and evaluation of biomarkers: Identification and evaluation of biomarkers for the behavior of head and neck tumors and response to radiotherapy - Tumor control probability (TCP) and normal tissue complication probability (NTCP) - Range of motion of the cervical spine - Evaluation of voice disorder/voice quality - Sarcopenia and reduction of muscle mass depending on radiation exposure	—

Measure

Time frame

- Long-term survival and tumor control: disease-specific survival (DSS), overall survival (OS), local control (LC), and locoregional control (LRC) - Quality of life: disease-specific quality of life according to EORTC-QLQ-C30 and QLQ-HN43 - Long-term toxicities: Frequency of late toxicities grade = 2 toxicities (12 weeks after end of RT until end of follow-up) - Dependence on percutaneous endoscopic gastrostomy (PEG) - Identification and evaluation of biomarkers: Identification and evaluation of biomarkers for the behavior of head and neck tumors and response to radiotherapy - Tumor control probability (TCP) and normal tissue complication probability (NTCP) - Range of motion of the cervical spine - Evaluation of voice disorder/voice quality - Sarcopenia and reduction of muscle mass depending on radiation exposure

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026