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

Phase 4

• Conditions: HNSCC UICC III/IV; C00-C14; C30; C31; C32; Malignant neoplasms of lip, oral cavity and pharynx; Malignant neoplasm of nasal cavity and middle ear; Malignant neoplasm of accessory sinuses; Malignant neoplasm of larynx

• Registration Number: DRKS00013900
• Lead Sponsor: Hals-Nasen-Ohrenklinik Universitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-05
• Study Completion: 2020-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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

- 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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 +).<br>- 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.<br>- 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.<br>