De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity

Who is this study for? Adult patients with Oropharynx Squamous Cell Carcinoma that are eligible for adjuvant radiotherapy
What treatments are being studied? Radiochemotherapy
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection

• Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board

• Good general state (ECOG performance status 0 or 1)

• Adequate compliance to ensure closely follow-up

• Patient's consent and written consent

• Neck dissection of at least the tumor bearing side

⁃ Additional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be fulfilled):

• pT3 and R0 and / or

• histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis

⁃ Additional Inclusion Criteria Arm high risk (at least one of the criteria must be fulfilled):

• residual tumor (R1 status) and / or

• pathologic stage T4 (pT4) status and / or

• more than 3 infected lymph nodes and / or

• extracapsular extension of at least one lymph node metastasis

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
University Clinic Dresden
RECRUITING
Dresden
University Clinic Essen
RECRUITING
Essen
University Clinic Frankfurt
RECRUITING
Frankfurt Am Main
University Clinic Freiburg
RECRUITING
Freiburg Im Breisgau
University Clinic Heidelberg
RECRUITING
Heidelberg
LMU Munich University Hospital
RECRUITING
München
TUM University Hospital
RECRUITING
München
University Clinic Regensburg
RECRUITING
Regensburg
University Clinic Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Mechthild Krause, Prof.
mechthild.krause@uniklinikum-dresden.de
+49 351 458 2238
Backup
Fabian Lohaus, MD
fabian.lohaus@uniklinikum-dresden.de
+49 351 458 2238
Time Frame
Start Date: 2018-11-29
Estimated Completion Date: 2032-11-30
Participants
Target number of participants: 304
Treatments
Experimental: Interventional Arm A - HPV(+)
De-escalation Radio(chemo)therapy - Level 1
Experimental: Interventional Arm B - HPV(+)
De-escalation Radio(chemo)therapy - Level 2
Active_comparator: Observational Arm A - HPV(-)
Standard Radio(chemo)therapy
Active_comparator: Observational Arm B - HPV(+)
Standard Radio(chemo)therapy
Sponsors
Leads: Technische Universität Dresden
Collaborators: Radiation Oncology Working Group of the German Cancer Society, German Cancer Research Center, National Center for Tumor Diseases (NCT) Dresden, National Center for Tumor Diseases, Heidelberg

This content was sourced from clinicaltrials.gov

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