HNSCC
Conditions
Brief summary
The two curative treatment modalities for patients with HNSCC - primary chemoradiation (CRT) or primary surgery (often combined with postoperative (C)RT) - are both associated with serious side effects for which reason further stratification, optimization and personalization of treatment is urgently needed. As novel quantitative image analyses are a promising tool for further risk stratification, the investigators training a three-dimensional Convolutional Neural Network on 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging and clinical / histopathological data of a multicentric, retrospective cohort of 1200 patients treated with primary CRT and 800 patients treated with primary surgery at Charité and cooperation institutes in order to predict individual treatment-specific outcomes and identify patients with excellent outcome after primary CRT or primary surgery or unfavorable outcome for both. The trained algorithm of the artificial intelligence will be validated in a prospective trial to see if predicted loco-regional control and recommended treatment strategies are reliable. In total 250 curative HNSCC patients, treated with CRT or primary surgery, will be enrolled on this prospective validation trial with observational character, while biomarker, clinical and FDG-PET data are collected from these patients and follow-up visits will be concluded.
Interventions
OTHERObservation
Observation Study
Sponsors
Helmholtz-Zentrum Dresden-Rossendorf
Max-Delbrück-Centrum Berlin
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients older than 18 years with diagnosed HNSCC, attending the Department of Radiooncology and Radiotherapy or the Department of Oral and Maxillofacial Surgery at Charité for a treatment with curative intension ( R(C)T or primary surgery / combined). * All patients received as pretherapeutic diagnostic method a 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging
Exclusion criteria
* Patients with HNSCC who cannot be treated in a curative approach * Patients with HNSCC treated in a curative approach but unable to receive FDG PET imaging before start of treatment * Data from patients who have withdrawn their study consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional Control | 2 years | Freedom from local progression within the first two years after treatment. Failure of locoregional control is defined as relapse of tumor confirmed by biopsy or if biopsy is inadequate or not feasible, consisting clear image morphology (MRI / CT / PET) during routine follow-up check-ups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life Quality | 2 years | Collection of questionares regarding life quality before treatment and during routine follow-up check-ups after treatment regarding to the European Quality of Life Instrument (EURO-QOL) |
| Metastases-free survival | 2 years | Freedom of Metastasis within the first two years after treatment during routine follow-up check-ups; Metastasis must be confirmed by biopsy or clear image morphology if a biopsy is not feasible (MRI / CT / PET) |
| Toxicity of Treatment | 2 years | Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups |
| Progression-free Survival | 2 years | alternative for Overall survival; event in PFS defined as disease progression or death |
Countries
Germany
Contacts
Primary ContactJulian Weingärtner, Dr. med.
Backup ContactSebastian Zschaeck, PD Dr. med.
Outcome results
None listed