Condition: Head-and-neck Squamous Cell Carcinoma · Sponsor: Technische Universität Dresden
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects. Patients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.
This description comes directly from the study's public registry record.
Mechthild Krause, Prof. · +49 351 458 2238 · mechthild.krause@uniklinikum-dresden.de
Fabian Lohaus, MD · +49 351 458 2238 · fabian.lohaus@uniklinikum-dresden.de
Always discuss trial participation with your own doctor first.
| University Clinic Tübingen | Tübingen, Baden-Wurttemberg, Germany | Recruiting |
| University Clinic Essen | Essen, North Rhine-Westphalia, Germany | Recruiting |
| University Clinic Dresden | Dresden, Saxony, Germany | Recruiting |
| Charité - Universitätsmedizin Berlin | Berlin, Germany | Not Yet Recruiting |
| University Clinic Frankfurt | Frankfurt am Main, Germany | Recruiting |
| University Clinic Freiburg | Freiburg im Breisgau, Germany | Recruiting |
| University Clinic Heidelberg | Heidelberg, Germany | Recruiting |
| LMU Munich University Hospital | München, Germany | Recruiting |
| TUM University Hospital | München, Germany | Recruiting |
| University Clinic Regensburg | Regensburg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03396718