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

NCT03396718 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Head-and-neck Squamous Cell Carcinoma

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)

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • National Center for Tumor Diseases (NCT) Dresden

    collaborator UNKNOWN

  • National Center for Tumor Diseases, Heidelberg

    collaborator OTHER

  • Radiation Oncology Working Group of the German Cancer Society

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Mechthild Krause, Prof. · University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2029-11-30
Completion
2032-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396718 on ClinicalTrials.gov