Spots Global Cancer Trial Database for Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
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Trial Identification
Brief Title: Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
Official Title: Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial
Study ID: NCT03865277
Conditions
Study Description
Brief Summary: The trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.
Detailed Description: Previous preclinical data and a prospective validated patient cohort have shown that patients with head and neck squamous cell carcinoma, whose tumours are hypoxic after 2 weeks of primary radiochmeotherapy, have a significantly lower chance of locoregional tumour control. The multi-center trial evaluates the value of radiation dose escalation based on hypoxia detection by 18F_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy (70 Gy) or radiochemotherapy with escalated radiation dose (77 Gy). An additional interventional arm includes a carbon ion boost to 77 Gy. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy. Secondary endpoints include acute and late toxicity (CTCAE 5.0), regional tumor control, overall survival, disease free survival, distant metastases, kinetics analysis of dynamic FMISO-PET scans, Quality of life (QoL). The hypothesis is that local tumour control 2 years after radiochemotherapy is higher in the dose escalated compared to the control arm.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology, Freiburg, Baden-Wuerttemberg, Germany
Department of Radiation Oncology Heidelberg University Medical School, Heidelberg, Baden-Wuerttemberg, Germany
Universitätsmedizin Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim, Baden-Wuerttemberg, Germany
Uniklinikum Wuerzburg, Würzburg, Bavaria, Germany
Mechthild Krause, Dresden, Saxony, Germany
Universitätsklinikum Leipzig, Leipzig, Saxony, Germany
Charité University Hospital, Berlin, , Germany
Ludwig-Maximilian-Universität, Klinikum Großhadern, München, , Germany
Contact Details
Name: Mechthild Krause, Prof.
Affiliation: University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Role: STUDY_CHAIR
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