Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 4:34 AM
Study NCT ID:
NCT06831903
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy of Head and Neck Cancer With SIB
Sponsor:
Wuerzburg University Hospital
Organization:
Study Overview
Official Title:
Simultaneous Integrated Boost in the Primary and Adjuvant Therapy of Head and Neck Cancer: Quality Control Registry Prospective Longitudinal Obervation Trial
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: