Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2027

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
RADIATION

dose-escalated radiochemotherapy

"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy).~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if hypoxic and randomized to the intervention arm, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases \> 2 cm.~Radiotherapy is always applied with 5 fractions per week."

RADIATION

dose-escalated radiochemotherapy with carbon ion boost

"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial.~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if hypoxic and treated in the study site Heidelberg, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases \> 2 cm using a carbon ion boost.~Radiotherapy is always applied with 5 fractions per week."

RADIATION

standard radiochemotherapy

"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy).~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region and 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes.~Radiotherapy is always applied with 5 fractions per week."

Trial Locations (8)

13353

Charité University Hospital, Berlin

68167

Universitätsmedizin Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim

69120

Department of Radiation Oncology Heidelberg University Medical School, Heidelberg

79106

Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology, Freiburg im Breisgau

81377

Ludwig-Maximilian-Universität, Klinikum Großhadern, München

97080

Uniklinikum Wuerzburg, Würzburg

01307

Mechthild Krause, Dresden

04103

Universitätsklinikum Leipzig, Leipzig

All Listed Sponsors
lead

Technische Universität Dresden

OTHER