Testing lower radiation doses after surgery for HPV-positive head and neck cancer
Tests lower radiation doses after surgery in adults with HPV-positive head and neck cancer.
Plain-language title generated from the registry record
Registry title: De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Key facts
- Where
- Berlin, Dresden, Essen, Frankfurt am Main, Freiburg im Breisgau, Heidelberg, München, Regensburg, and Tübingen, GermanySee the 10 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had surgery for squamous cell cancer of the oropharynx and need radiotherapy or radiochemotherapy afterwards. It tests a lower radiation dose.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Squamous cell carcinoma of the oropharynx removed by surgery, with neck lymph node removal. Intermediate-risk arm: pT3 with R0, and/or 1-3 lymph nodes with cancer and no spread beyond the node capsule. High-risk arm: residual tumor (R1), pT4, more than 3 cancerous lymph nodes, and/or spread beyond the node capsule.
- Earlier treatment
- Surgery to remove the cancer, with neck dissection of at least the tumor side. The tumor board must advise radiotherapy or radiochemotherapy after surgery. No earlier radiation that could overlap with the new dose.
- Biomarker or test result
- The trial title and summary describe HPV-positive (HPV-associated) cancer. The inclusion criteria list does not state a test result.
Main reasons for not taking part
- Distant metastasis, or R2 resection or visible tumor left after surgery
- More than 7 weeks between the last operation and the planned start of radiation
- Another cancer in the last five years, or any other head and neck cancer
- Pregnant or breastfeeding women
- More than 30 packyears of smoking: these patients join only the observation arms, not the intervention arms
Read by machine on 9 November 2026.
Where in Germany
- Charité Universitätsmedizin BerlinBerlin, GermanyNot yet recruiting
- University Clinic DresdenDresden, GermanyTaking people
- University Clinic EssenEssen, GermanyTaking people
- University Clinic FrankfurtFrankfurt am Main, GermanyTaking people
- University Clinic FreiburgFreiburg im Breisgau, GermanyTaking people
- University Clinic HeidelbergHeidelberg, GermanyTaking people
- LMU Munich University HospitalMünchen, GermanyTaking people
- TUM University HospitalMünchen, GermanyTaking people
- University Clinic RegensburgRegensburg, GermanyTaking people
- University Clinic TübingenTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT03396718
- Record updated
- 22 September 2025
- Original description
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.Read full original descriptionShow less
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity
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.
Inclusion: 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.
Exclusion: R2 resection or macroscopically visible residual tumor after surgery; interval between last operation and planned irradiation start > 7 weeks; contraindication against a guideline-appropriate adjuvant radiation or radiochemotherapy according to the clinical risk constellation; Pre-irradiation with risk of dose overlap; participation in another clinical trial if further experimental therapy is necessary or the treatments/ protocols are mutually exclusive (e.g. altered chemotherapy, additional consolidation chemotherapy). Allowed is the additional participation in observation studies or supportive therapy studies; tumor disease in the last five years before the beginning of the study (except basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors with similar prognosis which are considered to be very likely to be cured); malignant tumor disease in the head and neck region, regardless of interval and prognosis; diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial; Patients with a cumulative nicotine abuse > 30 packyears. These patients are not included in the intervention arms, but are always included in the observation arms (regardless of HPV status); radiologically presumed or histologically confirmed distant metastasis; no neck dissection; pregnant or lactating women; evidence that the participant is not expected to comply with the study protocol (e.g. lack of cooperation); missing written consent.