Validation and comparison of cervical lymph node staging after primary radio- or chemoradiotherapy of locoregionally advanced head and neck carcinomas - a prospective, multicenter study

Validation and comparison of cervical lymph node staging after primary radio- or chemoradiotherapy of locoregionally advanced head and neck carcinomas - a prospective, multicenter study - HN-Onkoimage-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013900

Enrollment

100

Registered

2018-11-05

Start date

2018-06-14

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

HNSCC UICC III/IV C00-C14 C30 C31 C32

Interventions

Group 1: Staging of the cervical lymph nodes three months after completion of a curative intended radio- or chemoradiotherapy of head and neck squamous cell carcinoma by means of ultrasound, computed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Initial diagnosis HNSCC UICC III / IV, incl. CUP syndrome with tumor board decision for primary radiotherapy or chemoradiotherapy (RCT) (planned 66-72Gy total dose) or radioimmunotherapy with cetuximab - p16 status (immunohistochemistry) from the biopsy of the primary tumor or lymph node tissue - Patient age at least 18 years

Exclusion criteria

Exclusion criteria: - Contrast allergy - Palliative situation after completion of radiotherapy or chemoradiotherapy after tumor board consensus - patient not eligible for ND - Pregnancy / Breastfeeding - non-consenting patient - ECOG> 2 (Classification of the Eastern Cooperative Oncology Group)

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, positive and negative predictive values and misclassification rates of sonography, CT and PET / CT in the assessment of cervical lymph node status after the TNM system (N0 vs. N +). The comparison of the diagnosed N status is compared with the result of the salvage ND at ycN + and to the staging result (CT, sonography, if necessary PET / CT) after another 6-9 months at ycN0.	—

Measure

Time frame

Sensitivity, specificity, positive and negative predictive values and misclassification rates of sonography, CT and PET / CT in the assessment of cervical lymph node status after the TNM system (N0 vs. N +). The comparison of the diagnosed N status is compared with the result of the salvage ND at ycN + and to the staging result (CT, sonography, if necessary PET / CT) after another 6-9 months at ycN0.

—

Secondary

Measure	Time frame
- Pairwise comparisons of interventions (sonography, CT, PET / CT) for sensitivity, specificity, positive and negative predictive values and misclassification rate in the assessment of cervical node status after the TNM system (N0 vs. N +). - Comparison of the interventions (sonography and CT) with respect to staging according to RECIST criteria. It should be noted here that, for technical reasons, a direct comparability of the RECIST report between ultrasound and CT is only possible to a limited extent. In sonography and CT, quite different target and non-target lesions can be defined and tracked. Nevertheless, the final result after o.g. Criteria: complete response; Partial response; Progress; Stable disease and thus validated for sonography. - Evaluation of the interobserver reliability of the procedures in terms of the score of the most prominent LK of staging by score, staging to RECIST, TNM system and Hopkins criteria.	—

Measure

Time frame

- Pairwise comparisons of interventions (sonography, CT, PET / CT) for sensitivity, specificity, positive and negative predictive values and misclassification rate in the assessment of cervical node status after the TNM system (N0 vs. N +). - Comparison of the interventions (sonography and CT) with respect to staging according to RECIST criteria. It should be noted here that, for technical reasons, a direct comparability of the RECIST report between ultrasound and CT is only possible to a limited extent. In sonography and CT, quite different target and non-target lesions can be defined and tracked. Nevertheless, the final result after o.g. Criteria: complete response; Partial response; Progress; Stable disease and thus validated for sonography. - Evaluation of the interobserver reliability of the procedures in terms of the score of the most prominent LK of staging by score, staging to RECIST, TNM system and Hopkins criteria.

—

Countries

Germany

Contacts

Public ContactJulian Künzel

Klinik- und Poliklinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Regensburg

julian.kuenzel@ukr.de094194419460

Outcome results

None listed

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