De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
DELPHI
1 other identifier
interventional
304
1 country
10
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 - 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2032
September 22, 2025
September 1, 2025
11 years
October 24, 2017
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of locoregional recurrences
measured from the last day of treatment
24 months after end of treatment
Secondary Outcomes (6)
overall survival
60 months and 5 years after end of treatment
acute toxicity
3 months after end of treatment
late toxicity
24 months after end of treatment
quality of life of cancer patients
24 months after end of treatment
quality of life - disease specific
24 months after end of treatment
- +1 more secondary outcomes
Study Arms (4)
Interventional Arm A - HPV(+)
EXPERIMENTALDe-escalation Radio(chemo)therapy - Level 1
Interventional Arm B - HPV(+)
EXPERIMENTALDe-escalation Radio(chemo)therapy - Level 2
Observational Arm A - HPV(-)
ACTIVE COMPARATORStandard Radio(chemo)therapy
Observational Arm B - HPV(+)
ACTIVE COMPARATORStandard Radio(chemo)therapy
Interventions
55/ 59,4 Gy (intermediate / high risk group)
48,4/ 55 Gy (intermediate / high risk group)
60/ 66 Gy (intermediate / high risk group)
Eligibility Criteria
You may qualify if:
- 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
- pT3 and R0 and / or
- histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University Clinic Tübingen
Tübingen, Baden-Wurttemberg, 72016, Germany
University Clinic Essen
Essen, North Rhine-Westphalia, 45147, Germany
University Clinic Dresden
Dresden, Saxony, 01307, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
University Clinic Frankfurt
Frankfurt am Main, 60590, Germany
University Clinic Freiburg
Freiburg im Breisgau, 79106, Germany
University Clinic Heidelberg
Heidelberg, 69120, Germany
LMU Munich University Hospital
München, 81377, Germany
TUM University Hospital
München, 81675, Germany
University Clinic Regensburg
Regensburg, 93053, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mechthild Krause, Prof.
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of Radiotherapy and Radiation Oncology
Study Record Dates
First Submitted
October 24, 2017
First Posted
January 11, 2018
Study Start
November 29, 2018
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
November 30, 2032
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share