Clinical trial · Interventional
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head-and-neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| De-escalation radio(chemo)therapy - Level 1 | Radiation | — | UNRESOLVED |
| De-escalation radio(chemo)therapy - Level 2 | Radiation | — | UNRESOLVED |
| Standard radio(chemotherapy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Interventional Arm A - HPV(+)
- description
- De-escalation Radio(chemo)therapy - Level 1
- interventionNames
- Radiation: De-escalation radio(chemo)therapy - Level 1
- type
- EXPERIMENTAL
- label
- Interventional Arm B - HPV(+)
- description
- De-escalation Radio(chemo)therapy - Level 2
- interventionNames
- Radiation: De-escalation radio(chemo)therapy - Level 2
- type
- ACTIVE_COMPARATOR
- label
- Observational Arm A - HPV(-)
- description
- Standard Radio(chemo)therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLinge A, Lohaus F, Appold S, Troost EGC, Abdollahi A, Kowal S, Buttner D, Lock S, Baumann M, Krause M. De-escalation of adjuvant radio(chemo)therapy for patients with HPV-positive head and neck squamous cell carcinoma: study protocol for a phase I trial to reduce late toxicity (DELPHI). BMC Cancer. 2026 Apr 29;26(1):542. doi: 10.1186/s12885-026-16050-x. PMID 42057029