De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas (DELPHI)
Head-and-neck Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Head-and-neck Squamous Cell Carcinoma focused on measuring Head and neck cancer, Oropharyngeal cancer, postoperative, radiotherapy, radiochemotherapy, de-intensification, HPV
Eligibility 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
Sites / Locations
- Prof. Anca-Ligia GrosuRecruiting
- Prof. Daniel ZipsRecruiting
- Prof. Claus BelkaRecruiting
- Prof. Stephanie CombsRecruiting
- Prof. Claus RödelRecruiting
- Prof. Martin StuschkeRecruiting
- Prof. Mechthild KrauseRecruiting
- Prof. Volker Budach
- Prof. Jürgen DebusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Interventional Arm A - HPV(+)
Interventional Arm B - HPV(+)
Observational Arm A - HPV(-)
Observational Arm B - HPV(+)
De-escalation Radio(chemo)therapy - Level 1
De-escalation Radio(chemo)therapy - Level 2
Standard Radio(chemo)therapy
Standard Radio(chemo)therapy