HYpofractionated, Dose-redistributed RAdiotherapy with protons and photons to combat radiation-induced immunosuppression in head and neck squamous cell carcinoma

HYpofractionated, Dose-redistributed RAdiotherapy with protons and photons to combat radiation-induced immunosuppression in head and neck squamous cell carcinoma - HYDRA trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53777

Enrollment

154

Registered

2022-10-10

Start date

2022-12-15

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

Head and neck squamous cell carcinoma

Interventions

The HYDRA dose prescriptions are, in 20 fractions (instead of the conventional 35 fractions): - Inhomogeneous focal boost on the macroscopic gross tumor volume (GTVprimary tumor and GTVnodes) on FDG

=3 for normal tissue. - Simultaneous integrated boost (SIB) on the clinical target volume (CTV-P1 = GTV+5mm): 55Gy - Elective field / CTV-P2 (GTV+10mm): 40Gy Patients who receive the HYDRA interven

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx who are eligible for curative intent proton or photon therapy, with or without concurrent radiosensitizer

Exclusion criteria

Exclusion criteria: • Previously treated by irradiation in the head and neck region • Chronic inflammatory disease or immune disorders • Other malignant disease (unless in situ carcinoma or BCC) within the last 2 years.

Design outcomes

Primary

Measure	Time frame
Safety of HYDRA-protons and HYDRA-photons in terms of radiation-induced grade 3-4 late toxicity, physician-reported by CTCAE v5.0, monitored until 1 year after the last patient has completed HYDRA. HYDRA is randomized with standard of care for translational research purposes; a direct comparison of toxicity will statistically not be conclusive and is outside the scope of this study.	—

Secondary

Measure	Time frame
• Objective response rate 3 months after HYDRA (group 1 and 3), defined by radiological response on CT-scans or MRI using RECIST version 1.1 and/or histopathological confirmation of residual disease, in comparison to standard of care (group 2 and 4, respectively). • Efficacy of HYDRA (group 1 and 3) in terms of in-field and nodal elective field tumor control, 1 year after the last patient is included, in comparison to group 2 and 4, respectively. • Numbers and phenotype of peripheral immune cell populations in blood and tissue at baseline, related to patient- and tumor characteristics (tumor localization, TNM status, tumor subtype, comorbidities etc.), in group 1-4. • Temporal changes of immune markers obtained in blood during/after treatment at 6 timepoints as specified in Figure 1, and differences in these changes between group 1-4.	—

Measure

Time frame

• Objective response rate 3 months after HYDRA (group 1 and 3), defined by radiological response on CT-scans or MRI using RECIST version 1.1 and/or histopathological confirmation of residual disease, in comparison to standard of care (group 2 and 4, respectively). • Efficacy of HYDRA (group 1 and 3) in terms of in-field and nodal elective field tumor control, 1 year after the last patient is included, in comparison to group 2 and 4, respectively. • Numbers and phenotype of peripheral immune cell populations in blood and tissue at baseline, related to patient- and tumor characteristics (tumor localization, TNM status, tumor subtype, comorbidities etc.), in group 1-4. • Temporal changes of immune markers obtained in blood during/after treatment at 6 timepoints as specified in Figure 1, and differences in these changes between group 1-4.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026