head and neck squamous cell carcinoma (HNSCC)
Conditions
Interventions
Group 1: Elective Nodal Irradiation (ENI) representing the standard of care with a simultaneous integrated boost
Group 2: Reduced Elective Nodal Irradiation (RNI) comprising volumetric and dosimetric
Sponsors
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • newly diagnosed, non-metastatic squamous cell carcinoma of the oral cavity, p16-negative oropharynx or p16-positive oropharynx with =30 packyears of smoking history, hypopharynx, and larynx with planned definitive radio(chemo)therapy • PET/CT has been performed or is scheduled • age = 18 years • performance status ECOG 0/1 • adequate contraception (hormonal contraception, intrauterine devices, sterilization, or abstinence) • ability to understand the characteristics of the clinical trial and the personal consequences of study participation • patient education and written informed consent
Exclusion criteria
Exclusion criteria: • patient's refusal to participate in the study • radiotherapy following neck dissection or extensive resection • previous radiotherapy in the head and neck region • p16-positive oropharyngeal carcinoma with <30 packyears of smoking history • T1-2 N0 glottic laryngeal carcinoma without indication for elective nodal irradiation • nasopharyngeal carcinoma • pregnant or breastfeeding women • participation in another competing clinical study or observation period of competing trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to reduce radiation-induced lymphopenia. The primary endpoint is the nadir of absolute lymphocyte counts in the peripheral blood during radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary objectives, this trial will 1) evaluate patient-reported outcome (PROMs) and quality of life (QoL) at 12 months after radio(chemo)therapy 2) compare overall grade 3 to 4 short-term toxicity events measured by TAME from treatment onset to three months after the end of radiotherapy 3) compare the rate of gastric tube placement/start of parenteral nutrition and duration of tube/i.v. feeding 4) compare the maximum weight loss and the weight loss at the first follow-up (6 weeks after radiotherapy) 5) compare the cumulative dose per body-surface area of cisplatin applied during chemoradiation 6) assess if isolated regional out-of-field metastases that would have been covered by current guidelines and CT- based staging are documented in <15% of patients in the intervention arm within 12 months after radio(chemo)therapy 7) compare local, regional, and distant control rates 24 months after radio(chemo)therapy, overall survival and progression-free survival 8) univariate and multivariate analysis of the factors impacting the nadir of absolute lymphocyte counts Explorative analyses will 1) correlate subsets of circulating immune cells with treatment arms, dose distributions, and clinical outcomes. 2) assess biomarker potential of longitudinal nanopore sequencing of circulating cell-free tumor DNA (cf-DNA), circulating extracellular vesicle (EV) cargo, including RNA, and the therapy response, measured by multiparametric MRI and early posttreatment FGD-PET. 3) design and test the automatization of target volume delineation and radiotherapy planning and models for normal tissue complication probabilities (NTCP) / tumor control probabilities (TCP), and lymphocyte dynamics using machine learning. | — |
Countries
Germany
Contacts
Public ContactThomas Held
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Outcome results
None listed