Clinical Research Directory
Browse clinical research sites, groups, and studies.
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Sponsor: Technische Universität Dresden
Summary
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.
Official title: De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
304
Start Date
2018-11-29
Completion Date
2032-11-30
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
De-escalation radio(chemo)therapy - Level 1
55/ 59,4 Gy (intermediate / high risk group)
De-escalation radio(chemo)therapy - Level 2
48,4/ 55 Gy (intermediate / high risk group)
Standard radio(chemotherapy)
60/ 66 Gy (intermediate / high risk group)
Locations (10)
University Clinic Tübingen
Tübingen, Baden-Wurttemberg, Germany
University Clinic Essen
Essen, North Rhine-Westphalia, Germany
University Clinic Dresden
Dresden, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
University Clinic Frankfurt
Frankfurt am Main, Germany
University Clinic Freiburg
Freiburg im Breisgau, Germany
University Clinic Heidelberg
Heidelberg, Germany
LMU Munich University Hospital
München, Germany
TUM University Hospital
München, Germany
University Clinic Regensburg
Regensburg, Germany