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RECRUITING
NCT03396718
NA

De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas

Sponsor: Technische Universität Dresden

View on ClinicalTrials.gov

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

Interventions

RADIATION

De-escalation radio(chemo)therapy - Level 1

55/ 59,4 Gy (intermediate / high risk group)

RADIATION

De-escalation radio(chemo)therapy - Level 2

48,4/ 55 Gy (intermediate / high risk group)

RADIATION

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