Clinical study on radiation dose reduction in patients with cervical lymph node metastatic HPV (human papilloma virus)-positive squamous cell carcinoma of the oropharynx based on tumor tissue oxygenation as detected by 18F-fluoro-misonidazole positron emission tomography (18F-FMISO-PET)

Clinical study on radiation dose reduction in patients with cervical lymph node metastatic HPV (human papilloma virus)-positive squamous cell carcinoma of the oropharynx based on tumor tissue oxygenation as detected by 18F-fluoro-misonidazole positron emission tomography (18F-FMISO-PET) - DOREDOROX

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035984

Enrollment

Registered

2025-03-06

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Patients with HPV-positive T1-2, N1.2c, M0 oropharyngeal (tonsils, soft palate, base of tongue) carcinoma

Interventions

Group 1: Patients with HPV-positive T1-2, N1-2c, M0 oropharyngeal carcinoma or patients with HPV-positive Tx N1-2c, M0 cervical CUP syndrome (Cancer of Unknown Primary) who show good oxygenation in 18

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with HPV-positive T1-2, N1-2c, M0 oropharyngeal carcinoma - Patients with HPV-positive Tx N1-2c, M0 cervical CUP syndrome (Cancer of Unknown Primary) - Age: = 18 years - With or without resection of the primary tumor mentioned above and indication for radiotherapy - Written informed consent of the study participants after written and oral verbal informed consent

Exclusion criteria

Exclusion criteria: - Any previous radiotherapy in the head and neck area - Previous chemotherapy in the context of newly diagnosed oropharyngeal carcinoma - Previous chemotherapy or radiotherapy within the last three years - Distant metastasis - Patients with histologically HPV-negative squamous cell carcinoma (PLECAs) - T-stage greater than T2 (i.e. patients with T3 or T4 oropharyngeal PLECAs are excluded) - Age < 18 years - Patients for whom MR (magnetic resonance imaging) imaging is contraindicated (e.g. in the presence of implants not suitable for MR)

Design outcomes

Primary

Measure	Time frame
2-year overall survival	—

Secondary

Measure	Time frame
a) 2-year local control of the tumor b) Toxicities with the reduced (30Gy) radiation dose c) Quality of life (using the standard EORTC questionnaire) d) Correlation between the 18F-FMISO-PET findings and the MR findings	—

Countries

Germany

Contacts

Public ContactHaralampos Gouveris

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; Hals-Nasen-Ohrenklinik und Poliklinik

Haralampos.Gouveris@unimedizin-mainz.de+496131177361

Outcome results

None listed

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