Clinical trial · Observational
Radiotherapy of Head and Neck Cancer With SIB
Simultaneous Integrated Boost in the Primary and Adjuvant Therapy of Head and Neck Cancer: Quality Control Registry Prospective Longitudinal Obervation Trial
- 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)
Title: Simultaneous Integrated Boost in Primary and Adjuvant Therapy of Head and Neck Tumors: Quality Control Registry Prospective Longitudinal Observational Study Short Title: Radiotherapy for Head and Neck Tumors with SIB Objective: To evaluate the efficacy and safety of definitive and adjuvant radio(chemo)therapy with simultaneous integrated boost (SIB) in patients with head and neck cancers. The study aims to assess local and regional control, overall survival, metastasis-free survival, therapy-related toxicities, and quality of life. Study Design: A prospective, longitudinal, non-interventional registry study documenting real-world outcomes and quality measures of therapy applied according to existing clinical guidelines.
Conditions
Conditions (4)
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 |
| Quality of Life (QOL) | — | UNRESOLVED | — |
| Radiotherapy, Conformal (IMRT) | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Head and neck radio(chemo)therapy
- description
- Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg between October 2019 and October 2034.
Primary outcomes (2)
- measure
- Local control rate.
- timeFrame
- From the date of treatment initiation until local recurrence or last follow-up, whichever occurs first, assessed up to 60 months.
- description
- Key aspects of local tumor control include: No Evidence of Tumor Growth: The absence of measurable or observable increase in the size of the tumor at the primary site. Tumor Response to Treatment: Complete Response (CR): Disappearance of all signs of cancer at the primary site. Partial Response (PR): Reduction in tumor size without complete disappearance. Persistence of Stable Disease: The tumor remains unchanged in size and does not spread locally beyond the treated area. Time Frame: 5 years from treatment start. Assessment Methods: Clinical Examination: Evaluation of the treated site for physical signs of recurrence. Imaging Techniques: CT, MRI, or PET scans to detect residual or recurrent disease. Biopsy: When clinically indicated, to confirm recurrence if suspected.
- measure
- Regional tumor control rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg Exclusion Criteria: * missing informed consent * mental or physical disorders leading to inability to understand and/or fill the quationary * judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures
References
Publications (0)
Data not yet available