276
Participants
Start Date
July 1, 2024
Primary Completion Date
September 30, 2025
Study Completion Date
September 30, 2027
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."
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."
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."
Charité University Hospital, Berlin
Universitätsmedizin Mannheim, Klinik für Strahlentherapie und Radioonkologie, Mannheim
Department of Radiation Oncology Heidelberg University Medical School, Heidelberg
Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology, Freiburg im Breisgau
Ludwig-Maximilian-Universität, Klinikum Großhadern, München
Uniklinikum Wuerzburg, Würzburg
Mechthild Krause, Dresden
Universitätsklinikum Leipzig, Leipzig
Technische Universität Dresden
OTHER