Reducing radiation therapy for HPV-positive head and neck cancer
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity
This study is testing if giving less radiation after surgery helps people with HPV-positive head and neck cancer avoid side effects while still keeping the cancer under control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Tübingen, Baden-Wurttemberg and 9 other locations) |
| Trial ID | NCT03396718 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with HPV-positive squamous cell carcinoma of the oropharynx or larynx who have undergone surgical removal of their tumors.
Not a fit: Patients with HPV-negative tumors or those not requiring adjuvant therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer side effects for patients while still effectively treating their cancer.
How similar studies have performed: Other studies have shown promising results with de-escalation strategies in HPV-positive cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tübingen, Baden-Wurttemberg and 9 other locations
- University Clinic Tübingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- University Clinic Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
- University Clinic Dresden — Dresden, Saxony, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Not_yet_recruiting)
- University Clinic Frankfurt — Frankfurt am Main, Germany (Recruiting)
- University Clinic Freiburg — Freiburg im Breisgau, Germany (Recruiting)
- University Clinic Heidelberg — Heidelberg, Germany (Recruiting)
- LMU Munich University Hospital — München, Germany (Recruiting)
- TUM University Hospital — München, Germany (Recruiting)
- University Clinic Regensburg — Regensburg, Germany (Recruiting)
Study contacts
- Study coordinator: Mechthild Krause, Prof.
- Email: mechthild.krause@uniklinikum-dresden.de
- Phone: +49 351 458 2238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.