Clinical trial NCT06831903: Radiotherapy of Head and Neck Cancer With SIB
Official title: Simultaneous Integrated Boost in the Primary and Adjuvant Therapy of Head and Neck Cancer: Quality Control Registry Prospective Longitudinal Obervation Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life (QOL)
Head and Neck Cancer
Radiotherapy Side Effect
Radiotherapy, Conformal (IMRT)
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: This study is a prospective, longitudinal, non-interventional quality control registry focused on the application of simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) in the primary and adjuvant treatment of head and neck cancers. The primary objectives are to evaluate local and regional control rates, overall survival, tumor-specific survival, and metastasis-free survival. The study also aims to document acute and late treatment-associated toxicities, patient-reported quality of life, and recurrence patterns in relation to delivered radiation doses.

Patients with histologically confirmed malignancies of the head and neck region (excluding basal cell carcinoma) who are indicated for definitive or adjuvant radiotherapy or radiochemotherapy will be included. Treatment planning involves individualized IMRT/VMAT-based approaches with SIB techniques designed to escalate doses to high-risk tumor regions while sparing surrounding healthy structures, thereby reducing toxicity. The treatment is provided in compliance with national guidelines and inter-disciplinary tumor board recommendations.

Evaluation of Adverse Events The study employs the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires-QLQ-C30 and H\&N35-to systematically assess treatment-related adverse events (AEs) and their impact on quality of life. These standardized tools are administered at baseline, at the end of treatment, and during follow-up visits.

The EORTC QLQ-H\&N35 questionnaire, specifically tailored for head and neck cancer patients, captures detailed information on a wide range of symptoms and treatment-related toxicities, including but not limited to:

Swallowing and Oral Function:

Dysphagia (difficulty swallowing) Speech problems (articulation and clarity) Xerostomia (dry mouth) Sticky saliva

Sensory Impairments:

Altered taste and smell Hearing loss

Pain and Discomfort:

Pain in the mouth, throat, or jaw Soreness or discomfort in the treated area

Respiratory Symptoms:

Breathing difficulties Nasal congestion or discharge

Nutritional Challenges:

Difficulty eating or maintaining weight Nutritional supplementation requirements

Emotional and Social Impact:

Body image concerns Social functioning and isolation Financial burden associated with treatment

Other Common Toxicities:

Skin reactions in the irradiated area Fatigue and general physical discomfort These adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE), enabling consistent reporting of the severity and frequency of toxicities.

Data Collection and Statistical Analysis The collected data will include baseline patient characteristics, treatment parameters, and longitudinal quality-of-life scores. Outcomes will be analyzed to identify correlations between reported toxicities, dosimetric parameters, and clinical outcomes, such as recurrence patterns and survival metrics.

The statistical methodology includes:

Descriptive statistics for baseline demographics and treatment variables. Kaplan-Meier estimates for survival analysis. Cox proportional hazards models to explore the influence of clinical and treatment-related factors on survival and recurrence.

Correlation analyses to assess the relationship between dosimetric variables and recurrence patterns.

Significance of the Study This study seeks to complement clinical trial data with real-world evidence on the implementation of SIB-IMRT in head and neck cancer treatment. By systematically capturing and analyzing treatment-related toxicities and quality-of-life metrics, the findings aim to refine therapeutic protocols, enhance patient outcomes, and inform strategies to mitigate adverse events. Moreover, the integration of recurrence pattern analysis and ontogenetic lymphatic mapping could offer valuable insights for future treatment planning.

Eligibility criteria: 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

Primary outcomes:
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.
measure: Regional tumor control rate
timeFrame: From the date of treatment initiation until regional recurrence or last follow-up, whichever occurs first, assessed up to 60 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of treatment initiation until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months.
measure: Disease-Specific Survival (DSS)
timeFrame: From the date of treatment initiation until disease-specific death or last follow-up, whichever occurs first, assessed up to 60 months.
measure: Metastasis-Free Survival (MFS)
timeFrame: From the date of treatment initiation until the first occurrence of distant metastasis, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months.
measure: Secondary malignancies
timeFrame: From Enrollment to the 5 years after the end of treatment.
measure: Toxicities
timeFrame: From the date of enrollment until the occurrence of acute or late therapy-related toxicities, death, or last follow-up, whichever occurs first, assessed up to 60 months.
measure: General quality of life (EORTC QLQ-30)
timeFrame: Enrollment, end of radiotherapy (week 7 from start), week 6-8 after the end of radiotherapy, 12, 24, 36, 48, 60 Month after the end of radiotherapy or death from any cause, or last follow-up, whichever occurs first.
measure: Organ specific quality of life (EORTC QLQ-H&N35)
timeFrame: Enrollment, end of radiotherapy (week 7 from start), week 6-8 after the end of radiotherapy, 12, 24, 36, 48, 60 Month after the end of radiotherapy or death from any cause, or last follow-up, whichever occurs first.
measure: Factors Influencing Recurrence Patterns
timeFrame: From treatment start until first evident recurrence. Censoring for all patients without recurrence at 5 Years.
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Clinic of Wuerzburg
state: Bayern
Study officials:
affiliation: University Clinic of Wuerzburg, Department of Radiation Oncology
name: Victor Lewitzki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: