Clinical trial · Observational
Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
Observational Study on Biomarkers in Head and Neck Cancer
NCT02059668CI-TRIAL-00060047HNprädBiocompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care. Potential biomarkers from a previous retrospective study will be validated in this prospective study.
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker analyses head & neck cancer tissue, blood specimen | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biomarker analyses head & neck cancer tissue, blood specimen
- description
- Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer.
- interventionNames
- Biological: Biomarker analyses head & neck cancer tissue, blood specimen
Primary outcomes (1)
- measure
- local recurrence free survival
- timeFrame
- after 2 years
Secondary outcomes (3)
- measure
- disease-free survival
- timeFrame
- after 2 years
- measure
- metastases-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Primary radiochemotherapy: * Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx * Stage III or IV without distant metastases * Patient is able to participate in regular tumor follow-up care * planned irradiation dose 69-72 Gy * planned overall treatment time 38-54 days * written informed consent of the patient * general condition according to WHO 0-2 * planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 180 mg/m2 body surface, divided in several separately doses) Adjuvant radiochemotherapy: * Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx * surgery, existence of one or more of the following risk factors for local recurrence: * extracapsular growth of a minimum of one lymph node metastasis * R1 resection * pT4 tumor and more than 3 affected lymph nodes * Patient is able to participate in regular tumor follow-up care * planned irradiation dose 63-66 Gy * planned overall treatment time 44-48 days * planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 200 mg/m2 body surface, divided in several separately doses) * written informed consent of the patient * general condition according to WHO 0-2 * time since last surgery \<56 days (8 weeks) Exclusion Criteria: Primary radiochemotherapy: * distant metastasis * contraindication against a cisplatin-based chemotherapy * planned total irradiation dose \<69 Gy and \>72 Gy * planned overall treatment time \>54 days or \<38 days * Patient is incapable of giving consent * previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas * other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient * tumor-independent diseases or conditions which reduce the survival probability of the patient to \<2 years or which affect the follow-up over 2 years * no written informed consent * induction chemotherapy * pregnancy or lactation Adjuvant radiochemotherapy: * distant metastasis * contraindication against a cisplatin-based chemotherapy * planned total irradiation dose \< 63 Gy or \> 66 Gy * planned overall treatment time \> 48 days or \< 44 day * Patient is incapable of giving consent * previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas * other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient * tumor-independent diseases or conditions which reduce the survival probability of the patient to \<2 years or which affect the follow-up over 2 years * no written informed consent * pregnancy or lactation
References
Publications (2)
- DERIVEDTawk B, Halec G, Rein K, Schwager C, Knoll M, Wirkner U, Held T, Weykamp F, Liermann J, Hoerner-Rieber J, Kurth I, Balermpas P, Rodel C, Fleischmann M, Linge A, Lock S, Lohaus F, Tinhofer I, Krause M, Stuschke M, Grosu AL, Schafer H, Zips D, Combs SE, Belka C, Stenzinger A, Herold-Mende C, Baumann M, Schirmacher P, Debus J, Abdollahi A. A tumor DNA-Methylome derived signature of Hypoxia Identifies HPV-negative head and neck cancer patients at risk for distant metastasis after postoperative radiochemotherapy (PORT-C). Radiother Oncol. 2026 Apr;217:111433. doi: 10.1016/j.radonc.2026.111433. Epub 2026 Feb 9. PMID 41672251
- DERIVEDNiu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grun J, Rodel F, Grosu AL, Multhoff G. Comparison of the composition of lymphocyte subpopulations in non-relapse and relapse patients with squamous cell carcinoma of the head and neck before, during radiochemotherapy and in the follow-up period: a multicenter prospective study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG). Radiat Oncol. 2021 Jul 31;16(1):141. doi: 10.1186/s13014-021-01868-5. PMID 34332614