FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Olomouc
About this trial
Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area
Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1
Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Disqualifiers
Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)
Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer
Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
Trial design
Design model
Parallel
Treatments tested in this trial
Dose escalation
RadiationDose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN \> 2cm
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Dose escalationExperimental treatment 1 intervention
Group B: Standard fractionationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Complete response rate
response rate
Time frame
2-year2
Locoregional progresion free survival
locoregional progresion free survival
Time frame
2-year3
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
acute radiation-induced events
Time frame
3 months4
Rate of late radiation-induced events according to CTCAE 5.0
late radiation-induced events
Time frame
2-yearSecondary outcomes
1
Overall survival
overall survival
Time frame
4 years2
Distant metastasis free survival
distant metastasis free survival
Time frame
4 years3
Change in QoL according to the standardised EQ-5D questionnaire
QoL according to the standardised EQ-5D questionnaire
Time frame
2 years4
Rate of new hypoxic areas after two weeks of radiotherapy
rate of new hypoxic areas after two weeks of radiotherapy
Time frame
2 week after start of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Olomouc
Lead sponsor
Masaryk Memorial Cancer Institute
Collaborator
University Hospital Ostrava
Collaborator
Source ClinicalTrials.gov