Actively Recruiting
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Led by Technische Universität Dresden · Updated on 2025-09-22
304
Participants Needed
10
Research Sites
730 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
G
German Cancer Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Condition after surgical removal of squamous cell carcinoma of the oropharynx and adequate lymph node dissection
- Indication for adjuvant radiotherapy or radiochemotherapy recommended by interdisciplinary tumor board
- ECOG performance status 0 or 1 indicating good general health
- Ability and willingness to comply with close follow-up
- Signed informed consent
- Neck dissection performed on at least the tumor-bearing side
- For intermediate risk arm: pT3 with R0 resection and/or 1 to 3 lymph nodes involved without extracapsular spread
- For high risk arm: residual tumor (R1 status) and/or pathologic stage T4 and/or more than 3 affected lymph nodes and/or extracapsular extension of lymph node metastasis
You will not qualify if you...
- History of smoking exceeding 30 pack-years; such patients are excluded from intervention arms but may be observed
- Presence of distant metastases confirmed by imaging or histology
- R2 resection or visible residual tumor after surgery
- No neck dissection performed
- More than 7 weeks between last surgery and planned start of radiation
- Contraindications to guideline-based adjuvant radiation or radiochemotherapy
- Previous malignant tumors within 5 years before study except certain cured skin or cervical/breast lesions
- Any prior malignant tumor in head and neck region regardless of timing or prognosis
- Prior radiation treatment with overlapping dose risk
- Participation in other clinical trials requiring conflicting experimental therapies
- Conditions preventing understanding of the trial nature and consequences
- Pregnancy or breastfeeding
- Expected non-compliance with study protocol
- Lack of written informed consent
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University Clinic Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72016
Actively Recruiting
2
University Clinic Essen
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
3
University Clinic Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
4
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Not Yet Recruiting
5
University Clinic Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
6
University Clinic Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
7
University Clinic Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
8
LMU Munich University Hospital
München, Germany, 81377
Actively Recruiting
9
TUM University Hospital
München, Germany, 81675
Actively Recruiting
10
University Clinic Regensburg
Regensburg, Germany, 93053
Actively Recruiting
Research Team
M
Mechthild Krause, Prof.
CONTACT
F
Fabian Lohaus, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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