Status:
RECRUITING
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
German Cancer Research Center
National Center for Tumor Diseases (NCT) Dresden
Conditions:
Head-and-neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 - ...
Detailed Description
For all patients taking part in the study the HPV status of the resected tumor will be determined centrally by p16 immunohistochemistry and confirmation will be done by HPV DNA assessment using Polyme...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2032
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT03396718
Start Date
November 29 2018
End Date
November 30 2032
Last Update
September 22 2025
Active Locations (10)
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1
University Clinic Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72016
2
University Clinic Essen
Essen, North Rhine-Westphalia, Germany, 45147
3
University Clinic Dresden
Dresden, Saxony, Germany, 01307
4
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353