Reducing radiation therapy for HPV-positive head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of reducing the dose of postoperative radiotherapy or radiochemotherapy in patients with HPV-positive squamous cell carcinoma of the oropharynx and larynx. Patients will be categorized based on their HPV status and risk factors, with HPV-positive patients receiving a lower radiation dose compared to standard treatment. The study aims to determine if this de-escalation can minimize therapy-related side effects while maintaining effective cancer control. The trial will monitor outcomes and safety over a two-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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
* R2 resection or macroscopically visible residual tumor after surgery
* no neck dissection
* 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
* 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
* 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.
* diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial
* 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

Where it's running

• University Clinic Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• University Clinic Essen
  Essen, North Rhine-Westphalia, Germany Recruiting
• University Clinic Dresden
  Dresden, Saxony, Germany Recruiting
• University Clinic Frankfurt
  Frankfurt am Main, Germany Recruiting
• University Clinic Freiburg
  Freiburg im Breisgau, Germany Recruiting
• University Clinic Heidelberg
  Heidelberg, Germany Recruiting

Study contacts

• Study coordinator: Mechthild Krause, Prof.
• Email: mechthild.krause@uniklinikum-dresden.de
• Phone: +49 351 458 2238

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

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• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.